chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT FELT SMALL LUMP FEW HOURS AFTERWARDS AT INJECTION SITE; FELT BODY ACHES; ALL RED (AT INJECTION SITE ONLY); FEELING A LITTLE TIRED; This spontaneous report received from a patient concerned a 62 year old male. 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once a total administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced subject felt small lump few hours afterwards at injection site. On MAR-2021, the subject experienced felt body aches. On MAR-2021, the subject experienced all red (at injection site only). On MAR-2021, the subject experienced feeling a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient felt small lump few hours afterwards at injection site, all red (at injection site only), felt body aches and feeling a little tired was not reported. This report was non-serious.
Patient was taken to ER for febrile seizure. Pt urinated on himself, was acting funny and drooling. Pt was treated in ER w/ fluids, TYLENOL and MOTRIN and then discharged.
Woke up next morning with hard lump around deltoid along with,  red burning rash from injection site radiating down to elbow.  Rash along biceps and lateral upper arm. Stinging sensation when arm is bumped or upon touching.  Injection site was red, hot and hard the next morning.
Pt woke near 12AM w/ intense nausea/stomach cramps. No fever - nothing new in diet. Got up to vomit, woke up on bathroom floor later in his own vomit. Intense watery stools after he came to along w/ pain/nausea all night - no other loss of counsciousness. Felt like he should go to ER, had no one to drive him. Felt somewhat better in AM, still intense nausea but no vomiting. No fever, no headache, no pain in neck/sign of head trauma from previous night. Heart rate slightly elevated 91 bpm - 113/73 at time of visit - 3:20 2/9/2021 Referred to primary care physician for a follow-up. Pt had minor issues with the first injection on 1/11/21 - palpable 1" knot around injection site for 1 week, pain & fatigue, night sweats.
Swelling and a lump at shot site and soreness.  Improved daily- Did not seek medical attention.
SWELLING AT INJECTION SITE. Ice applied and swelling deminished after 10 minutes.
Previously on 18 August 2021, patient had COVID-19 with chillls, headache, congestion, sore throst, cough, and GI symptoms. On 6 September 2021, for unclear reasons, he recieved monoclonal antibody injections. He subsequently reported burning in his lungs around 16 Sept, but otherwise recovered well. He enrolled in a serologic study to follow antibody response and other immune markers to matural infection and vaccination. He was working 2 jobs and began carrying a concealed weapon which caused discomfort while driving. He was under a lot of stress sue to the vaccination exemption process and working 2 jobs. He began having fatigue, dry mouth, difficulty swallowing, low back pain, and upper abdominal ...
this is 1 of  3 pt from this facility to devel an inj site rxn characterized by redness, swelling, warmth & a knot one day p/vax;pt was seen by MD;
Tenivac was inadvertently administered to a 4 year old patient; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four years old male patient who was inadvertently administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U5854AB, Exp date: 25-Jan-2020).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included POLIOMYELITIS VACCINE (INACTIVATED) [IPOL]   It is a actual medication error due to Inappropriate age at vaccine administration.  It was reported that dose of Tenivac was inadvertently administered to a 4 year old patient.  It was not reported if the patient experienced any adverse event following vaccination.  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.
Restricted breathing due to throat swelling, numbness; tingling and pain in fourth and fifth fingers of injection arm
pt recvd vax & 7 to 10 days later pt was admitted to hosp w/temp of 105;underwent workup for pneumonis including culture & biopsy which are neg so far;condition has worsened & is in the ICU as of the date of this report;
dizzy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and NAUSEA (nauseous) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). The patient was treated with MECLIZINE HCL at a dose of 25 mg as required and DIAZEPAM ongoing since an unknown date at a dose of 5 mg as required. On 25-Feb-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine Exposure during pregnancy) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Following vaccine, pt c/o headache, pain. After going home, pt c/o nausea, was told to update, did not call.  Msg left and pt returned call and pt stated she was better, and she had vomited.
1/20/04 Annual physician examination. Received pneumococcal vaccine polyvalent pneumovax 23 on the left upper arm. 1/21/04 Morning, noticed a mass of quarter size on the left side under jaw bone area. Rapidly expanding to tail of the parotid gland, painless, mobile. 3/16/04: Diagnosis: Myxofibrosarcomo intermediate grade, (also known as myxoid variant of malignant fibrous histocytoma).
Vaccine is placed in refrigerator on 08Nov2021 and administered on 09Nov2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 08Nov2021 and administered on 09Nov2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 08Nov2021 and administered on 09Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 08Nov2021 and administered on 09Nov2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned No Treatment information was reported.
Information has been received from a physician concerning a 71 year old male with pemphigus who on 02-JAN-2008 was vaccinated with ZOSTAVAX.  It was originally reported as VARIVAX, but was clarified by the health care provider to have been ZOSTAVAX.  Approximately 2 1/2 weeks post vaccination (approx 20-JAN-2008) the patient developed greater than 500 generalized pruritic pustular lesions, with "questionable" impetigo sparing his face.  The rash was also indicated by the reporter to have been chicken pox.  Medical attention sought was not specified.  The health care provider indicated that the rash was biopsied.  Treatment included fuconazole (DIFLUCAN) and a six day course of a steroid pack.  The reporter indicated that as of this report, the rash was worse.  A product quality complaint was not reported.  Additional information has been requested.
Swelling of face, tingling in mouth, all over body, Rapid Heart Rate, throat tightening. Hoarse Voice
injection site gets warm to the touch/ injection site especially gets hot with sun exposure; There is a kind of hardness in his arm at the injection site; also experienced fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure), VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site), PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management (Blood pressure) and Blood cholesterol abnormal (Cholesterol).    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure) and VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure) and VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported for indication Blood Pressure and Cholesterol with unknown medications   This case was linked to MOD-2021-333268 (Patient Link).
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients. No treatment medication provided.
Tight chest, mild wheezing, puffy face, red eyes, sneezing, and itchy throat.
Had a regular flu shot at Community Health Center. A day later feet, ankles and legs begin to swell with fluid. The second day the fluid begin to be in hands and arms. The third day my skin was "drum tight". On Sunday evening, Sept. 13, went to emergency room at hospital with high blood pressure, high pulse rate, concern for possible heart problem. Cardiologist recognized a different problem and brought in a kidney specialist. A needle biopsy of the kidney on Tuesday, Sept. 15, resulted in identification of the problem on Wednesday, Sept. 16. The diagnosis was Minimal Change Disease, which caused protein to "leak" from the kidney resulting in the edema. Had six albumin IV3, a was placed on 60mg of Prednisone, plus three high blood pressure medication, diuretic heart beat regulator drug, warfarin, and two other medicines. Many blood samples taken during hospitalization, all of which showed problems with protein and creatinine. Was released from the hospital on Monday, Sept. 28. Swelling initially went down after another 10 days at home, with continued high dosage of Prednisone. Was taken off diuretic and Prednisone was reduced to 30 mg /day. Other drugs have ba : some reduction in dosage. Complete blood test on Friday, October 10, shows most all blood date to be within range. Expect continued reduction in medication dosage over the next two months. I will take no more flu shots. One week with the flu is much better than two weeks in the hospital and several months of blood tests, doctor appointments, medication with significant side effects.
got a sore arm/left arm was sore/their arms hurt; This is a spontaneous report received from a contactable consumer (patient's wife), who reported for her husband (patient) that a 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 70-years, via an unspecified route of administration in left arm at 10:00 on 11Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis. No additional vaccines administered on same date of BNT162B2. Concomitant medications were not reported. In the evening on 11Mar2021, the patient got a sore arm/left arm was sore. Consumer mentioned that their arms hurt. Confirmed that she was referring to her husband. Her husband and she had that same thing in common, it was not catastrophic. If there is soreness, need to know how to gauge the symptoms. She states why would she call if it was common and expected, like a sore arm, not to the point where she would have to take medication or something. Clarified caller and her husband's arms hurt after the COVID vaccine. No treatment. No emergency room or physician office. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Noticed: redness, swelling and warmth the next morning to the left arm - injection site (reported to MD on 11/29/13).
my upper arm is still hurting me; i could not sleep all night; there is a little swelling in that area; My upper arm is still hurting me; I could not sleep all night; There is a little swelling in that area; It is like a stinging pain; It is hurting me like the most; My upper arm is still hurting me; I could not sleep all night; There is a little swelling in that area; It is like a stinging pain; It is hurting me like the most; today, it is hurting me like the most; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right (upper right arm) on 05Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, I got my first shot on 05Apr2021, the Pfizer one (Covid Vaccine) and my upper arm is still hurting me. Last night, I could not sleep all night and when I woke up this morning, I saw that there is a little swelling in that area. How long it takes for pain to go away? It is like a stinging pain. Consumer further stated, I took two Tylenol (treatment) this morning and I am putting an ice pack right now. Today (08Apr2021), it is hurting me like the most. The outcome of event my upper arm is still hurting me and today, it is hurting me like the most was not recovered and rest all was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a 19 months old male patient. The patient was vaccinated with ROTATEQ (lot number not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On 12-OCT-2011 and 18-SEP-2012 the patient experienced two incidents of intussusception and was hospitalized. The hospital was not identified. The patient had sought unspecified medical attention and received unspecified treatment. The outcome of the patient was unknown. Additional information has been requested.
Shingles; nerve tingling; scarring; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In June 2021, between 1 and 2 years after receiving Shingrix, the patient experienced shingles, tingling and scar. On an unknown date, the outcome of the shingles, tingling and scar were not recovered/not resolved.   It was unknown if the reporter considered the shingles, tingling and scar to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she received Shingrix vaccine. The patient experienced shingles and was still experiencing nerve tingling and scarring. The reporter consented to follow-up For tolerance refer linked case US2021AMR203662, same reporter for the second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203662:same reporter
fell down the stairs; hit his head; Patient was reported to have low BP; lost his balance, which has been off lately; minor concussion; 47 days since patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head) and HYPOTENSION (Patient was reported to have low BP) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse event (No reported medical history). Concomitant products included HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL), NAPROXEN, DIPHENHYDRAMINE and SIMVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BALANCE DISORDER (lost his balance, which has been off lately) (seriousness criterion hospitalization), FALL (fell down the stairs) (seriousness criterion hospitalization), HEAD INJURY (hit his head) (seriousness criterion hospitalization) and HYPOTENSION (Patient was reported to have low BP) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONCUSSION (minor concussion) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose). The patient was hospitalized for 5 days due to BALANCE DISORDER and CONCUSSION. At the time of the report, BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head), HYPOTENSION (Patient was reported to have low BP) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error
no adverse event; patient received ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report as received from a Licensed Practical Nurse to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided.      On 12-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T040207, expiration date of 18-JUL-2022, orally and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) lot# u7124AA expiration date of 13-JUL-2024, after a temperature excursion (product storage error) for prophylaxis. The temperature excursion was 49F and lasted 1 hour 24 minutes. There was no previous temperature excursion. No adverse event was reported.
Left arm swelling from size of a Nickle to the size of a tennis ball, swollen, hard, warm, ended up causing whole are to be warm.
right deltoid: moderately erythematous almost down to the elbow and almost up to the shoulder