chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen; experiencing a widening rash; joint pain in her neck to shoulder area; arms was itchy near the injection site; Nausea; Arm Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site) and FATIGUE (Fatigue) in a 59-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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Fatigue). On 03-Jan-2021, the patient experienced NAUSEA (Nausea). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arms was itchy near the injection site). On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash) and ARTHRALGIA (joint pain in her neck to shoulder area). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (joint pain in her neck to shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment details were not provided.; Sender'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.
09/02/2021 @ ~ 1:00 PM I received the Pfizer Covid Vaccine @ pharmacy. ~20 hours later I started to experience Flue like symptoms which got worse over the next three (3) days Along with the Flue symptoms, fever, headache, joint  muscle pain I started having loose Bowels which have persisted for weeks on and off.  On 09/21/2021 I returned from work with the same symptoms I had after the Vaccine only slightly milder.  I had a covid test which was negative on 09/22/2021 so I could return to work.  The symptoms lasted about 48 hours.  Still have issues with the loose bowels.  I have not felt well since receiving the Vaccine.
Cough, chest tightness, shortness of breath, vomiting, arthralgias, and voice change (raspy).
From correspondence received on 10/26/01, it was reported that a 77 year old female patient received a Fluzone SV '01-'02 vaccination on 10/19/01. 12-16 hours later the patient developed generalized hives and felt tightness in her throat. Treated with over the counter Benadryl and symptoms resolved.
C/o dizziness 5 mins after receiving Flu injection. BP R/arm 80/50; diaphoretic; A+Dx3; stat loss of concscious, regained consciousness after ammonia & 0.5 cc Epinephrited given SC L/arm stat. Placed in Trendelenberg position after O2
Here for appt. and 1 month behind on IZ's. Given DTAP, IPV and HIB/HEP-B at appt. Mom called at 14:30, stating the pt was screaming and crying non-stop for 20 minutes and lasted 3-4 hours. Discussed comfort measures and pt seen later that day to confirm pertussis reaction.
Woke up midnight violently shivering, fever was 102.  Managed fever with Tylenol and ibuprofen.  Fever, headache, and body aches last 52 hours.
pt recv vax 28AUG95 & 19OCT97 pt devel diarrhea for one day, rash on the back of the neck, chest & scalp & a poor appetite;pt was afeb;21OCT97 chickenpox was dx;
so sore everywhere; could not stay awake; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-092984). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 12May2021 as dose 2, single for covid-19 immunisation and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 11May2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for thyroid cancer. Medical history included Malignant neoplasm of thyroid gland (diagnosis/ lCD code: C73 (ICD-IO-CM)). The concomitant medications were not reported. The patient received first dose of bnt162b2 on an unknown date for covid-19 immunization. On 12May2021 the patient experienced so sore everywhere and could not stay awake. It was reported that the patient had been tried to get his blood sugar under control prior to starting Lenvima and patient was on Lantus. Patient reported that he was really tired, no energy, fatigue. Cause thought to be related to Lenvima and occurred while on Lenvima. Patient reported he received his second Pfizer COVID shot on 12May2021 and on same day the patient reported he was so sore everywhere and could not stay awake after the shot. Patient said those symptoms from the shot lasted for about 24 hours. Cause was not thought to be related to Lenvima but occurred while on Lenvima. Patient reported his tongue felt like it was burned, it hurts. Cause thought to be related to Lenvima and occurred while on Lenvima. Patient reported blurred vision up close but thought that might be from his Lantus he was took. Patient was unsured if it began prior to Lenvima, or after started Lenvima. Cause unknown but occurred while on Lenvima. Patient reported he was still tried to get his blood sugar under control, & this began prior to Lenvima. Patient reported his Blood Sugar has been in the high hundreds recently and it was 140 this morning (18May2021). Patient was taking Lantus to tried to control his Blood sugar. Cause was not stated to be from Lenvima but had continued to occur while on Lenvima. Action taken with Lenvima was unknown. The patient underwent lab tests and procedures which included blood glucose: high hundreds on an unknown date and blood glucose: 140 on 18May2021. The outcome of the events was resolved on an unknown date in May2021.
This spontaneous report was received from a 44 year old homosexual male consumer reporting on himself. His medical history and concurrent conditions were not reported. On an unknown date, the patient was initially vaccinated with GARDASIL, above the age of 26 and due to his physician's belief that he was in need for the product due to his participation in a homosexual lifestyle. Then he explained that his second dose on an unspecified date within the series was given with GARDASIL 9, (strength, dose, frequency, route, lot number and expiry dates for both vaccines were not provided). Concomitant medications were not reported. No adverse events were reported. The outcome of interchange of vaccine products and the causality between it and the vaccines were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since no contact details were provided.
Left lower extremity with 8 1/2x6 1/2cm of erythema and warm to touch. Slightly indurated at vaccination site slightly pruritic, non tender to touch. Follow up: site of reaction itchy.  Prescribed Benadryl and cool compresses.
lower extremity thrombophlebitis and fever on 07/04, elevated WBC. improved after antibiotics. US doppler pending
Moderna COVID-19 Vaccine EUA Woke the next day after vaccination of 1st dose to a fever, which progressively got worse throughout the day, peaking at over +102F (even with acetaminophen) at around 9pm, in addition to moderate headache and systemic full body aches and join pain. The combination of these adverse reactions left me completely bedridden until I awoke the following day (today, as I fill out this form), at which point the fever has subsided and the headache/body aches are more mild.
tested positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.  This is a spontaneous case concerning  a  patient of unknown gender and age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The events occurred approximately 9 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning  a  patient of unknown gender and age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The events occurred approximately 9 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Low Hemoglobin and Hematocrit in blood work. negative endoscopy and colonoscopy looking for blood loss.
I felt fine after my vaccination until about midnight. I felt weak, and generally sick - horrible. I felt like I had a fever and I felt like my heart was still thumping too hard. I felt nauseas and generally all over sick as a dog, weak as a kitten. And I was afraid as well, because it was midnight and I live alone. I thought about going to the ER due to my condition. I took my BP and it was 120/68 which is normal. I took my temperature and it was 96.7 and then I did my blood oxygen and it was 96 with a heart rate of 66 so all of my little at home tests were normal. I was no longer afraid. I took two baby aspirin and I drank a lot of water and I went to sleep. I did not feel good in the morning but due to my vitals being okay, I began to stop worrying. Around noon the day after my vaccine, I felt OK. I contacted my DR the next day and they called me back and I was fine at that point so said nevermind.
I woke up extremely cold and. shaking the day after my injection.      I became weak and dizzy .  I could not keep my balance and fell head first into the kitchen cabinet.  It was extremely hard to get up from the floor since I was very weak.   I used a cane to  walk around the house for the next two days.  My symptoms returned to normal 2 days  later.
This spontaneous report was received from a medical assistant concerning a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD, lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175: US-009507513-1806USA010176: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010180: US-009507513-1806USA010171: US-009507513-1806USA010179.
Information has been received from a physician concerning a female child who was vaccinated with a dose of varicella virus vaccine live. In approx March 2006, the pt broke out with a severe case of varicella, greater than 200 lesions. The lesions were everywhere including in her mouth and in her ears. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient with urticaria which started on 5/16/23. No fever.  Also has cold symptoms as well.
A healthcare professional reported that a 9 week old female received Prevnar, Comvax (MSD), IPV (Aventis Pasteur SA) and Tripedia (Aventis Pasteur Inc) on 5/11/01. The infant is a surviving twin, born prematurely at 29 weeks gestation. Concurrent conditions included pulmonary valve stenosis, and retinopathy of prematurity. One day, post vax, on 5/12/01, the infant experienced an episode of apnea, considered to be life threatening. The infant was taken to the ER and admitted. At the time of this report, the infant was still hospitalized.F/U info recd 8/15/01, from the reporter indicated that the pt was a male. who while hospitalized for 6 days underwent a sepsis evaluation in the pediatric intensive care unit.Past medical history was also significant for a left inguinal hernia, lot numbers, immunization routes and sites of administration o f the concomitant vaccines were also provided. the child recovered. MFG of the concomitant vaccines will be notified of this event.
Acute swelling of R wrist w/ effusion and warmth. She was started on Methylprednisolone 4 mg 2 BID X 5 days.
Syncope and collapse - loss of consciousness. Nausea and vomiting. Pt was admitted for observation and fluids. Lt arm red and painful - Pt to see pediatric neurology. Pt discharged in stable condition. Lt arm is still red.
PRETTY SEVERE JOINT PAIN; CHILLS; PRETTY SEVERE/EXTREME MUSCLE PAIN; FEVER; OVERALL FATIGUE; VERY MINOR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post primary vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 05-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-NOV-2021, for about 24-48 hours the patient experienced pretty severe muscle pain and joint pain, chills, fever and overall fatigue. She reported extreme muscle pain was still continuing currently and the other side effects went away. She was not sure about the injection arm and assumed left arm since she was right handed, no pain at injection site or might be very minor injection site pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty severe joint pain, chills, fever, overall fatigue, and very minor injection site pain on 07-NOV-2021, and had not recovered from pretty severe/extreme muscle pain. This report was non-serious.
Information has been received from a MA concerning an approximately 3.5 year old male who on 07/18/01 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced chickenpox. The pt's mother called from the ER and reported that her son was diagnosed with chickenpox. There was no product quality complaint involved. The reporter indicated that two other pt's (WAES # 0401USA00023 & 0401USA00024) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Headache, Diarrhea, Headache was only above left eye. Diarrhea 10+ loose stools. Swelling at injection site; fatigue Narrative:
I developed a twitch in my right eye within 4-5 hours of the shot that has not resolved apprx. 24 hours after the shot I experienced double vision that lasted 2 hours, the double vision has not returned as of now however the eye twitch has increased in severity. More common side effects I have experienced is fever (second day), chills (three days), body aches, headaches, sore/hoarse throat,  heart palpitations., extreme exhaustion, Injection site pain.
had joint pain everywhere for a day; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had joint pain everywhere for a day) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ARTHRALGIA (had joint pain everywhere for a day). In April 2021, ARTHRALGIA (had joint pain everywhere for a day) had resolved.            No concomitant medications was provided by the reporter No treatment medications was provided by the reporter   This case was linked to MOD-2021-362108 (Patient Link).
High temperature; Cough; Body aches; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high temperature, cough and body aches on an unspecified date after vaccination. The outcome with events was unknown.  Information on the lot/batch number has been requested.
Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: Swelling in axillary and torso on side of injection site
Following vaccination, patient reported "soreness" and "heaviness" to right arm, specifically to the proximal right bicep, radiating up to right axilla. Patient reported also numbness and "warmness" to right palm.  Denied history of this in the past. Denied pain or swelling at injection site to right deltoid. Vaccinator denied any issue with vaccine administration.   Patient was called on 3/19/22 for follow-up, call went straight to voicemail, no voicemail box set up. Patient instructed to follow up with her primary care provider at local facility on Monday if pain/numbness is worse or not improving.
8 days after my first dose I woke up with vertigo and chest pain.  I called 911, the EMTs arrived within in minutes.  they checked my vitals, gave me an EKG.  EKG was ok .. blood pressure was very very high.  They took me to the ER.  There they took a chest x-ray (looked ok),  tested me for Covid (negative), tested enzyme for heart attack (negative). They kept me under observation for an hour plus.  Things stabilized so I was discharged.
Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both legs.
Patient states felt reaction at site the evening of immunization, about 7 hours after getting vaccine stated she had a low fever. Morning after immunization patient states she passed out at home while in her kitchen.
pt recv vax 2NOV98 & pt found to be pregnant;The pregnancy was confirmed by quantitative HCG;LMP 16OCT98;expected date of delivery was 19APR999;pt exp a miscarriage;
Hives on my back and my chest/I broke out with all over with hives and all my chest; Not feeling good right now; I am itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101504152 (Pfizer).  A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Nov2021 16:00 (Lot number: FF2593) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot number: EN6199), administration date: 04Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Lot number: EN6207, Expiry Date: 31Jul2021), administration date: 25Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 02Nov2021 21:00, outcome "unknown", described as "Hives on my back and my chest/I broke out with all over with hives and all my chest"; MALAISE (non-serious) with onset 02Nov2021 21:00, outcome "not recovered", described as "Not feeling good right now"; PRURITUS (non-serious) with onset 02Nov2021 21:00, outcome "unknown", described as "I am itching". Therapeutic measures were taken as a result of urticaria, malaise, pruritus. The patient took medicine for her itching called Levocetirizine, for itching.   No follow-up attempts are possible. No further information is expected.
No adverse event reported. Patient received a third dose that was not approved for emergency use at his age. Parent stated that Dr. recommended he receive a third dose due to medical condition.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 ANEMIA OF CHRONIC DISEASE HYPOXIA 5/16/2021 ANEMIA OF CHRONIC DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 DM 2 W PERIPHERAL VASCULAR DISEASE HYPOXIA 5/16/2021 DM 2 W PERIPHERAL VASCULAR DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE HYPOXIA 5/16/2021 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 ADVANCE DIRECTIVE STATUS COUNSELING HYPOXIA 5/16/2021 ADVANCE DIRECTIVE STATUS COUNSELING
KNOT FORMING ON THE BEND INSIDE AREA OF RIGHT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced knot forming on the bend inside area of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knot forming on the bend inside area of right arm was not reported. This report was non-serious.
Hospitalized 8/14/22-8/21/22 fall, foot pain and redness, cough, tachypnea, sepsis, cellulitis, SOB, respiratory failure with hypoxia, PNA,
Swelling, Erythema, hot to touch  and slight tracking at and below injections site. Size approximately half dollar round and about 2.5 inches long. (right arm TDAP vaccine.   redness, slight swelling and tracking at and around injection site. Size about nickle size around and about 2 inches of tracking (left arm Meningococcal MCV4P)