chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach issues because bowels were swollen; Stomach issues because bowels were swollen; Allergic reaction; Itching; Hard lump; Swelling; Lymph node pain; Headache; Fatigue; Chills; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching) and MASS (Hard lump) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on side of injection (left arm) 5 years ago). Concomitant products included TOPIRAMATE (TOPAMAX) and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included centroid.; Sender's Comments: There is not enough information to assess stomach issue without an exact description and the patient's concomitant medication include omeprazolesuggestive of a digestive issue.  Additional information will be requested.  Based on temporal association, a causal association between the product use and the other events cannot be excluded. headache, fatigue, chills, nausea, fever, and lymph node pain are consistent with the known safety profile of the vaccine.
Client is 12.5 weeks gestation, with current EDD 09/13/2019. Client was inadvertently given Hepatitis A and Hepatitis B vaccines during this visit. Client did not complain of any signs or symptoms due to the vaccinations.
chills,  nausea, "can't use my arm"- only lift "an inch", pain "feels like someone shot me" "on fire" unable to find thermometer, headache, no appetite
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXEMIA 11/22/2022,  2/9/2023,  3/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No additional adverse event reported; Patient was administered Expired STERILE DILUENT reconstituted MMRII on 01/04/2023.; Patient was administered Expired STERILE DILUENT reconstituted MMRII on 01/04/2023.; This spontaneous report was received from a medical assistant and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot #W001518, expiration date: 13-JAN-2024, had been verified to be a valid number, and upon internal validation established as the same date, administered for prophylaxis (strength, dose, and route of administration were not provided) who was reconstituted with an expired sterile diluent, lot #T014300, expiration date: 03-DEC-2022 had been verified to be a valid number, and upon internal validation established as the same date (strength, dose, route of administration, and indication were not provided) (expired product administration). No additional adverse event.
Two weeks post-vaccination, on April 3, 2019, patient started rapidly developing petitchae and excessive bruising all over his body, followed by bloody noses and bleeding in the mouth and gums. On April 4, 2019, our Pediatrician sent him to the ER where he was  visually diagnosed  and then confirmed via a complete blood count (CBC) with Idiopathic thrombocytopenic purpura "ITP", requiring immediate hospitalization and treatment. The hematology group at Hospital took a complete blood count and struggled to find even 1  platelet in his CBC. Patient platelet counts were dangerously low and required an IV treatment of IVIG.  He responded to treatment with his platelet count rising to 19 within 24 hours (still well below the normal 150-450 range).
6-8 hours after vaccination heat, swelling, tenderness, arm/hand L. 24 hours increase at site. Generalized itching, temp 102 for 48 hours, rash and hives.  72 hours resolving - temp went normal and no itching.
Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA184281. (Same vaccine, same reporter). This case involves seven patients (age and gender not reported) who were vaccinated with dose of Fluzone QIV with two different lot numbers (Batch number: UI658AA and batch number: UI657AB expiration date 30 June 2017, route of administration were not reported) in the arm on an unspecified date. It was reported that did not have number of patient who received which lot number. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions not reported. Concomitant medication was not reported. On an unspecified date, following vaccination patients experienced upper arm redness, rash, swelling, itching, tenderness of vaccinated arm, generalized body aches, headache; neck pain; upset stomach; sore throat, and fatigue. Lab data and corrective treatment were not reported. Outcome of events reported as unknown. List of documents held by sender: none.
covid vaccine breakthrough   dose 1 3/20/21 Moderna 045A21A dose 2 4/17/21 Moderna 044B21A
When I woke up the next day, I had flu-like symptoms without a high fever.  My body shivered and I felt cold at times, my body ached, and I was very tired.  I had a rash on the trunk of my body on the side of the injection for about 3 days, a rash that is typical for me when I have a viral infection.  The rash was not itchy or raised.  Taking 1 ibuprofen every 4 to 6 hours helped alleviate these symptoms except for the fatigue and the rash.  The the upper arm at the site of the injection was red, feverish, and swollen.  This persisted for about 3 days.  Day 2, I felt much better but still was slightly fatigues and ibuprofen was no longer needed.  On Days 3 to 5, I notice I was emotionally unsettled feeling - kind of irritable and upset feeling.  I never felt this way before to my knowledge.  After Day 5 symptoms resolved except for the site of injection redness, soreness, and fever still resolving. By Day 7 I was back to normal.
Patient reports that she had excruciating pain in the back of her head, face swelling that resolved the next day, dizziness, nausea, and redness in the eye without any pain or discomfort. She did not seek any medical attention or treat any of her symptoms.
Received Pfizer vaccine 1/13/2021 and 2/4/2021. COVID-19 positive 1/31/2022. Presented to ER 1/31/2022. On room air throughout hospital admission. Received azithromycin and ceftriaxone. Discharged 2/7/2022. Prolonged hospitalization due to UTI and contaminated blood cultures, not COVID-19.
4 hours after shot: Arm soreness 10:30 am on 12/1 : headache, body ache, body chills and fatigue  3:30 pm on 12/1: continuation of previous symptoms.  Nausea, joint pain red rash at injection site with a streak of red going toward bicep 7am on 12/2: minor body fatigue injection site sore red rash still present 7 am on 12/3 slight body fatigue and joint pain, red rash still present, injection site sore ringing in my ears is noticed 8am on 12/4: rash is still present but very faint, injection site and rash site sore, ringing in ears present  7 am
student received 2 dose, 6 weeks apart, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 years old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that student received 2 dose, 6 weeks apart (inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medication included TUBERCULIN PPD.   On 16-Jul-2019, the patient received 1st dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site. On 27-Aug-2019 she also received 2nd dose of the same vaccine 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6021AA and expiry date: 29-Jul-2020 via unknown route in the right deltoid.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Severe brain fog, confusion, memory loss, cognitive decline, constant headaches. Primary care dr referred to neurologist that ran eeg and mri, found no problems. Prescribed prednisone which had no effect. Have taken otc aleve, excedrin which also has no effect. Still experiencing constant headaches and brain fog to date
Vomited without 3 minutes of getting vaccine - pale in color - symptoms resolved without 10 minutes.
Fatigue, myalgias, arthralgia, headache, nausea, fever to 101 degrees,
The vaccine was administered too high in the arm, possibly puncturing the bursa. Pain was felt down the arm at the time of administration, followed by joint soreness the day of. Low-grade fever, chills and body aches started that evening and lasted approximately 24 hours. Prolonged joint pain and limited range of motion in the affected shoulder has progressed since the day the vaccine was given,resulting in an MD visit and an oral steroid prescription.
Sore arm at injection site Mild malaise/fatigue/tiredness, appears to noticeably exacerbate with alcohol consumption.  Only resting and hydration with plain water were employed. No medications were used.
Dizziness; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FEELING ABNORMAL (Brain fog) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and FEELING ABNORMAL (Brain fog). At the time of the report, DIZZINESS (Dizziness) and FEELING ABNORMAL (Brain fog) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided. The patient stated that the events of first dose went away after 3 or 4 days.   This case was linked to MOD-2021-183128 (Patient Link).
COVID-19 virus test positive; Vaccination failure; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4419968-00.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, psoriasis, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "unknown", described as "COVID-19 virus test positive"; VACCINATION FAILURE (medically significant) with onset 02Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in COVID-19 Vaccine trial.  The reporter's assessment of the causal relationship of "covid-19 virus test positive" and "vaccination failure" with the suspect product(s) BNT162b2 was possibly related.  Causality for Humira (Adalimumab). The reporter's causality for the event(s) of tested positive for Covid with Humira (Adalimumab) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
FEVER DAY OF INJECTION, 3 DAYS LATER PRESENTS WITH LESS THAN 10 PAPULAR ERYTHMATEOUS ON HEAD, NO VESSICLES, NO CRUST YET. WAS EXPOSED TO COUSIN WITH WILD TYPE VARICELLA 3-4 WEEKS PRIOR
Recvd immun noted below in item #13 on 15NOV91; devel generalized fine red rash along w/tactile fever on 15NOV91;
Onset profound fatigue on 4/30/21 and ongoing. Cardiac dysrhythmias, new onset Elevated CK
Diffuse hives, onset 3 days after injection treated with Orap  med and Benadryl
This spontaneous report as received from a licensed nurse refers to a 4 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-JUN-2015, the patient received VARIVAX (Merck) 0.5 ml, subcutaneous, first dose, in nurse's office (Lot number, expiration date, dose and strength were not reported). Dose was subject to defrost cycling. No adverse effects were reported. Outcome was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I just felt my neck and my lymph nodes around collar bone and felt two lumps. The doctor told me that it's due to the vaccine and I didn't have to worry it was due to the vaccine. She told me the swelling would go down. No pain, just noticed they were swollen.
Red, raised, itchy area about 3-4 inches in diameter around site of injection. Warm to touch. Lasted about 1 week.   Started approximately 12 days after injection.
NOTE: I ALSO ATTMPTED TO FILED ONLINE BUT SITE CRASHED ON LAST PAGE , site got stuck on Military info - would not validate input or allow 'submit'. -----symptoms---- Same day (4/7): malaise, no fever, started 10PM Next day (4/8): Awakened to severe shaking (no fever or chills) 1AM, no fever (<99F), took 2x Tylenol at 3AM, shaking subsided Awakened to 103F fever (ear thermometer), no shaking 7AM 104F fever at 11AM, accompanied by vertigo/nausea when upright Took 2x Tylenol 1PM, fever reduced to 101F Fever at 101F until 10PM, then dropped to 99F with 15 min cold sweat 2nd day (4/9): Awoke with no fever or further symptoms, 8AM. Never got a sore arm.
100.9 fever starting about 24 hours after vaccination, high fever throughout night, chills, muscle aches, pain at site of injection, taking acetaminophen every six hours, fever subsided
Patient became pale and then experienced syncope.  Friend caught him as he fell.  Did not hit his head.   Patient was placed on the ground in Trendleberg.  Due to him not having eaten in the previous several hours, he was provided with orange juice after approximately 10 minutes.  Colour soon returned to his face.  He was placed upright and asked to wait for an additional 30 minutes.
about  the time stated earlier I began to experience severe pain in BOTH ARMS upper shoulder areas. could not move arms up or sideways. Pain was constant never ending. Throbbing and sharp pain like someone was sticking me with a knife from the inside trying to get out. About  3 to 4 weeks later I "woke up" and BOTH my WRISTS were in pain as well. Could not move them sharp pain at the wrist and also index to thumb pain . The wrist pain lasted for about 3 to 4 weeks then subsided. I still get wrist pain on occasion. The shoulder pain has subsided considerably BUT is still with me. I still have some pain moving my arms side to side  and upwards. With time it has gotten better but still hurts.
Approx 30 minutes after receiveing the vaccine, the patient developed intense itching, hives and sensation of throat swelling. Received Benadryl IM initially, required a repeat dose which was given Intravenously. No subsequent episodes of symptoms after that time.  Follow-up: Pt hospitalized at time of vaccination but reaction so severe that would have required hospitalization any way.
Shortness of breath developed 1 day after vaccine. Initially, it was only at night/early mornings (periods of rest), but has since progressed to occurring most of the day. As of today, symptoms have not subsided in nearly 3 weeks
Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist stated that 3 doses of the Moderna COVID-19 vaccine drawn in syringes were administered to patients on 22SEPT2021. The doses were beyond the 12-hours recommended by Moderna. Concomitant medications were not provided. Treatment information was not provided.
I noticed a rash on my neck about 1 day after the booster shot. I ended up getting a rash all over my torso, arms, neck, part of my face, I didn't have a rash on my legs. My temperature was about 99.7. The rash was gone by Saturday, but I was very lethargic until Monday. I had Moderna for the 1st and 2nd vaccine, and I developed a severe rash at the injection site that didn't show up until 3 or so days after the injection, and about 2 weeks for it to go away. My breathing was fine, I did have a bit of tightness. I have very bad allergies though, so I am kind of used to having tightness in my chest at times.
Information has been received from a physician concerning a 6 or 7 year old female who was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approximately 15-MAY-2006, the patient experienced a break through of mumps. Unspecified medical attention was sought. At the time of the report, the patient was recovered. A product quality complaint was not involved. Additional information has been requested.
Within 13 minutes of being given the vaccination her arm begin to swell and become numb.   She felt a prickling feeling up and down her arm.  Felt as if hand had disappeared.  Chest pains, weakness and tiredness.
nausea; dizziness; Progressed to tachycardia; heart rate from 60-120; This is a spontaneous report from a contactable consumer.   A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 18Dec2020 at 07:45, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient, approximately 15 minutes after shot, experienced mild nausea and dizziness. Progressed to tachycardia, heart rate from 60-120. Felt it racing and pounding. Went to emergency room for evaluation. The patient underwent lab tests and procedures which included heart rate: 60-120.  Therapeutic measures were taken as a result of the events and included electrocardiogram (EKG) and telemetry monitoring.
Presented to ED with dyspnea and bilateral extremity edema. BNP elevated. Cardiology consulted. Placed on scheduled diuresis. Echocardiogram with LVEF pf 23%. CT showed hemiparesis with bilateral circulation embolic strokes. Neurology consulted with anticoagulation recommended after waiting a few days then Started on eliquis. Pallative and ethics consulted for help with medical decision-making. Preparing for rehab facility when Covid test +. Pt. c/o abdominal pain, CT chest, abd, pelvis done. Found pancreatic mass with possible invade into duodenum. Evidence of metastatic disease in liver and lymph nodes. Comfort care initiated.
Headache, Myalgia, Pain/discomfort at injection site, chills, headache, severe joint and muscle pain, fatigue, nausea Narrative: employee states: approx 5 hours after vaccination these symptoms began- pain, discomfort, redness, swelling, and bruising at injection site general symptoms: chills, headache, severe joint pain, severe muscle pain, body aches, fatigue, and nausea As of 1/21/21, the majority of these symptoms have subsided except for muscle acne and pain at injection site with a slight bruise
Information has been received from a physician concerning a 15 year old female who on 04-MAR-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot#655670/1459U). Concomitant therapy included hepatitis B virus vaccine (manufacture unknown). On 04-MAR-2008, after receiving GARDASIL, the patient fainted. EPIPEN was used to revive the patient. Subsequently, the patient recovered from the event.  The patient decided to discontinue the dosing schedule of GARDASIL. The reporting physician considered syncope to be an other important medical event.  Additional information has been requested.