chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's arm began swelling and itching and was painful and red. Arm was also hot to the touch. Mom called on call provider and was advised to draw a line around the swollen area and if it continued to swell to go to the ER. Arm continued to swell so mom took patient to the ER and was given DECADRON.
Patient developed raised, itch, almost weeping rash on the inside elbow of the arm opposite the injection site. Still very itchy, no other symptoms.
Administered the listed vaccines that were due on 6/10/2021. Upon chart auditing noted that client's record that had been under the name and had additional vaccines added to it which invalidated several vaccines given on 06/10/2021. The client is in therapy and upon calling the client's medical case manager she reported she did not correctly report the client's name at the appointment on 06/10/2021 and that the name had been corrected. Advised medical case manager  that client had received additional doses of Tdap, Hep A, Hep B, Varicella, and Menactra since full shot record was not available at appointment in June. Medical case manager reported the client had no reactions after vaccine administration.
Information has been received from a licensed practical nurse concerning a 10 year-old male patient with no relevant medical history who in 1998 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 27-May 2003, the patient developed varicella described as "lesions on his face". On 28-May-2003, he was seen in the office and was moderately covered with at least 50 lesions, and had a fever. Treatment included acetaminophen (Tylenol) and "comfort measure". Medical attention was sought. There was no product quality complaint involved. No further information was available at this time. Additional information has been requested.
CHILLS; HIGH FEVER; NAUSEA; VERY TIRED; This spontaneous report received from a consumer concerned a 29 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, batch number: unkown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced high fever. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced very tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 F, 103.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, chills, nausea and very tired was not reported. This report was non-serious.
it's not painful, just annoying; can feel the tenderness on the lymph node area/It's sore, tender; Yesterday the whole right arm was sore ,a little sore; felt a little fatigued; under his right armpit where he got the injection it's a little tender; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen). On 15-Nov-2021, the patient experienced FEELING ABNORMAL (it's not painful, just annoying) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender). On 15-Nov-2021, FATIGUE (felt a little fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender), VACCINATION SITE SWELLING (a little swollen) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.
light dizziness; light sweating; dizziness; sweating profusely; sore arm; temp of 95; headache; exhausted; chills / Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely) and DIZZINESS (light dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID-19 about 6 weeks ago (prior to vaccination).).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering). On 07-Mar-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely). On 09-Mar-2021, the patient experienced DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain, at an unspecified dose and frequency. On 04-Mar-2021, PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering) had resolved. On 07-Mar-2021, DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely) had resolved. On 09-Mar-2021, DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
On 10/5/21 patient got vaccine, his sister came in on 10/11/21 and said patient on 10/5 was nauseated and throwing up. Took dramamine. On 10/10 patient found nonresponsive in his home. Currently hospitalized.
This spontaneous report as received from nurse via the company representative refers to a patient of unknown age and demographics. No concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL, subcutaneous. On an unknown date, the patient experienced syncope after being vaccinated with GARDASIL. The patient sought medical attention (details unspecified). Action taken with the suspect product was not applicable. The outcome of syncope was unknown. Causality was not reported. No product quality complaint reported. Additional information is not expected as the reporter contact information is not available.
High fever of 104, gave her a bath, and started having mild seizures in tub. Took her out of the tub, and she was turning a slight shade of purple/blue and was not responding to either myself or her father. Called 911 and she was rushed into the hospital by ambulance. Was given MOTRIN and fever had gone down to 98.0 rapidly. The doctors ruled out a bunch of ideas they had that could have induced fever. Thought it could have been UTI but could not get an urine sample via catheter. Never once was the word VACCINE brought up by doctor/nurse. MMR vaccine caused this reaction, and for that my daughters will never receive another.
The patient is a 17 year, 2 month old female who presents with worries. Note for "Worries": Patient's mom states the patient had a reaction to the flu shot given on 09/24/2015. C/o warmth, and redness at injection site (right deltoid). Patient is in today for evaluation of a reaction to an immunization that was given last Wednesday. Mom called me more than once this weekend. Review with the nurses reveals that the site that is reacting is the site of her flu immunization. Mom states that the reactive area started on Thursday and on Friday was only the size of a fifty cent piece. Child had a massage on Friday. I don't know if that could have affected but mom states that by Saturday the reactive area was "huge, bright red and very hot, although it did not seem tender." Patient at no time has developed any fever but she is on round the clock ibuprofen for her chronic pain condition. Mom states that it was swollen down to the elbow on Saturday and started to be visible below the elbow yesterday, which was Sunday. She has had no cough, rhinorrhea, vomiting or diarrhea, and is otherwise in her usual state (tube fed, trached, non-verbal, severe developmental delay and spastic CP).
4 hours post administration infant very fussy and immunization site with erythema & mild edema, tender at 7-8cm.
Pt returned to pharmacy 11/18/19 swelling & pain around injections slight rash around injection site
Approximately 72-96 h pronounced chills; diarrhea onset after chills subsided lasting 7 days; upper respiratory infection after subsiding of diarrhea (untreated). Upper and lower respiratory infections persisting approx. 3 mos patient experiencing dizziness since 3-28-2010.
given immun @ 10AM on 24APR97 dec appetite on that evening-next AM was feverish, & lethargic-R temp 105.4 @ home & @ our office sent to ER for eval; dx w/UTI @ hosp;
Within 72 hours, the pain at shot site intensified; however a rash also started that was very itchy and lasted approximately 17 days.  The pain in the arm lessened considerably, but the itching of the rash seemed worse at night when sleeping.  At night, I would apply Moisturizing Cream, which helped some.  Area was 6 " long & 4" wide.  Since I had no fever or any other symptoms & able to do  household chores, walking exercises, self-care appointment, &  lunch w/a family member, I did not call or report the reaction to my doctor, Dr. (he has recently been told about it).  By Feb. 28 it all stopped. No reaction at all to 2nd Moderna shot on 3/11/2021.
My arm started getting redder and redder from the injection site to the elbow and it was swelling and itchy and hot to the touch. I put lotion on it.
Pt was standing at check out when he became dizzy. He was sat in a chair and conversing with the nurse. His eyes rolled back and his head bent forward. Suddenly his head went back and his body was rigid and began to shake violently for approximately 20 seconds. He became conscious but disoriented about 45 secs after episode. EMS intervened and patient was assessed and monitored.  Patient refused transport to hospital but said he would contact his physician.
Injection site sensitivity, unable to have anything on my arm without significant pain. Movement of any kind of my left arm, even wiggling a finger, cause significant pain radiating throughout my entire left arm
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, and keflex allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received first booster of non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer (tozinameran) (Dose number in series 2). The patient received second booster of non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included fluoxetine hydrochloride (Prozac) for drug used for unknown indication.  On 20-FEB-2023, the patient experienced sore throat, sneezing, stuffy nose (suspected covid-19 infection) (Dose number in series 3). The patient was treated with drug Paxlovid (nirmatrelvir/ritonavir) from 02-MAR-2023 to 07-MAR-2023 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and tozinameran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Worsening of Chronic Hives, see statement on previous page.  Symptoms started days to weeks after the booster shot and have not cleared.  In fact, more than a month later they appear to be getting worse as my Zyrtec intake keeps having to be increased to control the hives.   Statement from previous page: "Since getting my booster my hives are not well controlled and I am now having to take 20mg - 30mg of Zyrtec per day to control them.  These reports are rampant across Chronic Urticaria boards including reports of people who did not have CU until after they received the vaccine and / or booster.  This is an issue that desperately needs to be looked into as when my CU and food sensitivities first started many years ago it was after my very first known flu vaccine.  It would seem as though there is some kind of connection between vaccines triggering  CU in certain individuals. And I will state, when uncontrolled this is a condition you would not wish on your worst enemy.  It's miserable and totally degrades your quality of life. "
Patient was given a dose of Infanrix inadvertently. He had already previously had the required number of doses needed. No adverse affects/reactions noted and his father was made aware of it.
Patient (employee) complaints of right arm pain and numbness radiating down to right elbow, forearm, and hand. She stated she was initially seen in Emergency Room, had multiple tests and x-ray that was negative, and was discharged with diagnosis of paresthesia. She then had a follow up visit on 10/22/20 under a workers' compensation claim.  An MRI of right arm was ordered; test is scheduled for 11/17/20 and pending (NOTE: THIS REPORT IS SUBMITTED ON BEHALF OF ANOTHER RN WHO WAS THE ADMINISTRATOR TO THIS INJECTION).
Received vaccine at 3:51 pm.  symptoms started at 4:45 pm.  Symptoms were: swelling of lips, burning sensation in mouth, felt hot and clammy.  Symptoms lasted approximately 45 minutes to 1 hour.
On 12/7/01, presented with rash, fever (T 100.4F), irritability and crying inconsolably. Hospitalized and treated with IV therapy of Rocephin. (Mother developed a similar rash on 12/8/01. Both mother and child improved in 48 hours). Discharge diagnoses also included urinary tract infection.
02/10/22 presents to ED for "Pre-syncope". PMHx of "hypothyroidism, dyslipidemia, history of CVA and dementia"
Initial side effects of nausea, loss of appetite and discomfort passed, but the side effect of severe long term fatigue remained. In bed for months. Still not back to baseline health yet.
Swelling, redness, itchy and warm to the touch, 2 days after vaccination. Treated in ER. DECADRON 8mg P.O. dose. KEFLEX 7.5 ml every 8 hours x 5 days.
Patient admitted to Hospital on 12/1/2021 for continued treatment of heart failure. Patient expired on 12/9/2021. Patient was fully vaccinated prior to admission.
THIS IS NOT AN ADVERSE REACTION REPORTING. PATIENT WAS ACCIDENTLY GIVEN THE MODERNA VACCINE AT THE AGE OF 17 YEARS OLD AND 9 MONTHS. MODERNA VACCINE IS FDA APPROVED FOR 18 YEARS AND OLDER.   PER COMPANU POLICY, A VAERS HAS TO BE REPORTED.   SECOND DOSE IS SCHEDULED 28 DAYS LATER   PATIENT IS DOING JUST FINE. HE DID NOT EXPERIENCE ANY SERIOUS SIDE EFEFCTS
Tested + 8/12. Arrived with worsening SOB. Fully vaccinated. Given monoclonal ab therapy in ER and observed overnight. Did not require O2. Discharged home after obs post monoclonal injection. Also given a dose of cefepime, decadron and fluids.
Pt woke up from nap with very small scattered "blotches" rash, reddened. Only 1 was fluid filled. Rash was itchy, no temp. Rash was on arms, legs, face & belly. Mom giving Benadryl. On 1/24/00, rash disappeared, pt is fine.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion).    No concomitant medications were reported.  Patient received Bivalent booster dose.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Storage condition at the time of excursion was Frozen storage. Unbroken cartons of vial size 2.5 and 5.5 ml were involved. Excursion duration was not known. Vials were returned to freezer and were still frozen. Visual inspection state was still frozen. Maximum or minimum temperature reached was unknown and only had manual twice a day recording and duration of excursion was unknown.  No treatment details were reported.
I was watching TV and I felt like I had indigestion/gas. My Watch alerted me that my heart rate had been high (over 125) for ten minutes. It continued to climb and my husband took me to a stand alone ER where they did an EKG and determined that I was experiencing atrial fibrillation. They started an IV of a medication designed to convert my heart back to normal sinus rhythm and administered an injection of a blood thinner into my abdomen. After more than an hour, my heart was still racing and I was still experiencing atrial fibrillation, so they found a hospital with an available bed and I was transported via ambulance. There, they continued to monitor my condition to determine if it would be necessary to sedate me and shock my heart, but at around 4:30 AM my heart returned to normal sinus rhythm. They weaned me off the IV medication and did an echocardiogram of my heart. I was released in the early afternoon. I have never had atrial fibrillation before this and I haven?t had a return of symptoms since leaving the hospital. I followed up with a Cardiologist and she said the echocardiogram the hospital performed and sent to her looked normal. She could not say for sure that this incident was caused by the vaccines, but cautioned me not to take two vaccines together in the future. I felt it was worth reporting and she agreed.
pt recvd vax & exp swelling at deltoid area below inoculation site; L axillary adenopathy w/in 24 s/p; pt seen by MD;
On 7/30/2022 my mother received a shingles vaccination from the Pharmacy. On 8/3/2022 she passed away.  An autopsy was performed and the pathologist's report includes the following for cause of death: "Active enteritis with diarrhea and probable electrolyte imbalance: complications of intravenous vaccine administration with laceration, left cephalic vein."
Narrative:  Patient experienced upper left arm redness from below injection site to medial aspect of upper arm to elbow following 2nd moderana covid vaccine - dose of 0.5ml .
Redness & some swelling around injection site on left arm.  Redness was about 4 inches in diameter.  Patients primary care doctor prescribed a 7 day course of cephalexin therapy.
Patient vaccinated w/ Pfizer vaccines on 1/18/21, 2/8/21 Tested positive for COVID19 by PCR on 7/29/21 after 2-3 wk h/o loss of smell, headache. To receive monoclonal antibodies on 7/30/21.
Local reaction at DTaP site, RDT.  Entire upper arm red, hot, very swollen.  Rec'd vaccine on 10-4 c/o pain that evening, rxn noted by mother on 10/5.
Borderline Delirius; Thyroid antibodies elevated; Body chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Borderline Delirius) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder (Guillian-Barre Syndrome).   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Borderline Delirius) (seriousness criterion medically significant), THYROIDITIS (Thyroid antibodies elevated), CHILLS (Body chills), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, DELIRIUM (Borderline Delirius) outcome was unknown, THYROIDITIS (Thyroid antibodies elevated) was resolving, CHILLS (Body chills) had not resolved and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-thyroid antibody: high.         Treatment was not reported/ unknown. Company Comment : Based on the current available infor:mation and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.