chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects; 1 inch by 1 inch area of redness/one can visibly see the area of redness; That area was also hard/the tissue in that area feels hard; hot to the touch/the tissue in that area feels hot; pain in the whole arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (side effects), ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness), INDURATION (That area was also hard/the tissue in that area feels hard), FEELING HOT (hot to the touch/the tissue in that area feels hot) and PAIN IN EXTREMITY (pain in the whole arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis and Psoriatic arthritis.    On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in the whole arm). On 01-Oct-2021, the patient experienced ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness). 01-Oct-2021, the patient experienced INDURATION (That area was also hard/the tissue in that area feels hard) and FEELING HOT (hot to the touch/the tissue in that area feels hot). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects), INDURATION (That area was also hard/the tissue in that area feels hard), FEELING HOT (hot to the touch/the tissue in that area feels hot) and PAIN IN EXTREMITY (pain in the whole arm) outcome was unknown and ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The 1 inch by 1 inch area of redness, was not exactly at the injection site but adjacent to it. The redness was still there but fading now.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-340988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Additional events, concomitant medication and medical history were added. Dosing details, reporter details and patient details were updated.
Patient became dizzy, lightheaded, and nauseous. He had a small to moderate amount of clear liquid emesis. He was told to stay seated, given water and a cold pack, and instructed in deep breathing. His symptoms subsided approximately 15 minutes later.
numbness; Tingling; Pain; Itching; had a significant spike in the neuralgia; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (had a significant spike in the neuralgia), HYPOAESTHESIA (numbness), PARAESTHESIA (Tingling), PAIN (Pain) and PRURITUS (Itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Post herpetic neuralgia (in left leg about 5 years ago). Concurrent medical conditions included Shingles (Recurrent, since I was 13 years old).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST HERPETIC NEURALGIA (had a significant spike in the neuralgia). On an unknown date, the patient experienced HYPOAESTHESIA (numbness), PARAESTHESIA (Tingling), PAIN (Pain) and PRURITUS (Itching). The patient was treated with LOSARTAN ongoing since an unknown date at a dose of 25 mg; TRAZODONE at a dose of 50 mg; MELATONIN at a dose of 10 mg; COLECALCIFEROL (VIT D [COLECALCIFEROL]) at an unspecified dose and frequency and CYANOCOBALAMIN (B 12) at a dose of 2000 mg. At the time of the report, POST HERPETIC NEURALGIA (had a significant spike in the neuralgia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed a course of steroids which unfortunately did not help.  No concomitant medication was provided.   This case was linked to MOD-2021-115893 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: significant follow up is added
Tachycardia, lightheaded, sweating started at 10 days after vaccine.
1st dose on Nov2021, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 1st November 2021, the patient received 1st dose of Shingrix in unknown arm via intramuscular route).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment:  The patient was not told by the doctor's office that, she needed to come back for the second Shingrix vaccine in 2 to 6 months (Inappropriate Schedule of Vaccine). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Heart palpitations; Constant cranial head/neck muscle tension; This is a spontaneous report from a contactable nurse (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), dose 1 intramuscular, administered in arm left on 21Dec2020 14:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins nos (DAILY VITAMINS). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced heart palpitations, constant cranial head/neck muscle tension. Heart palpitations required ER visit and cardiac consult. Constant cranial head/neck muscle tension also required ER and physician visit. The patient underwent lab tests and procedures which included thyroid/hormone: unknown results and cardiac evaluation: unknown results on unspecified date, Covid test PCR (Nasal Swab): negative on 30Dec2020. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249), dose 2 intramuscular, administered in arm left on 11Jan202112:00 PM as DOSE 2, SINGLE for covid-19 immunisation at Hospital. Therapeutic measures were taken as a result of heart palpitations, constant cranial head/neck muscle tension. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Pt unable to get dialysis related to testing positive for covid. Altered mental status related to metabolic encepholopathy. Pt also presented with anemia requiring blood transfusion, diarrhea, wounds and aspiration pnuemonia.  Family decided to transfer patinet to hospice, Patient expired on 07/04/2022 Hopitalization dates 06/14/2022-07/03/2022
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection (lot # M034894, expiration date: 11-NOV-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of between 32 to 36 degrees Fahrenheit for 6.5 hours. The digital data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002329:
Big red rash on where I had it; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Big red rash on where I had it) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Big red rash on where I had it). At the time of the report, RASH ERYTHEMATOUS (Big red rash on where I had it) outcome was unknown. Not Provided      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 were reported.  No treatment medication were reported.
Left deltoid (administration site) red 6" x 5", firm & warm to touch.
nurses gave a child 1 vaxelis and 1 ipol shot on the same day with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA341553.  This case involves a 2 months old female patient to whom nurses gave1 vaxelis and 1 ipol shot on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (Menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine Toxoid (Vaxelis); rotavirus vaccine and pneumococcal vaccine for Prophylactic vaccination.  On 03-Nov-2023, the patient received suspect IPV (VERO), Suspension for injection lot V1B902M expiry date: 02-Jun-2024 via intramuscular route in the right thigh for immunization (strength, dose: unknown).nurses gave 1 vaxelis and 1 ipol shot on the same day with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable.  Outcome: unknown for the 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 the 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.
On my left hand, the knuckle above my middle finger became more swollen and warm to the touch. I had a fever and it was 100.5. I couldn't move my muscles since it hurt. To lift the phone was very difficult. Awful headaches and stomach aches and moving anything hurt. My neck injury was hurt. Every joint was sore/inflamed. I felt like everything that has ever happened to me intensified and lasted 36 hours until I started able to move. My hand was still swollen. That head to toe muscle was good. I have had intermittent fatigue and brain fog. My taste is fine but my physical injuries were horrible. It was my body and muscular joints were in pain and feeling the flu like sick feeling. My body had a lot of intensity until 36 hours had passed. It feels like I'm a lot more weaker and I haven't been able to see my rheumatologist since 2012 when I had the fall for my neck injury. The blood work now is not good since it shows everything out of range and I am positive for DNS antibody. DS DN antibody for systemic lupus was 50.0. I had this bloodwork and I don't know why all these things were out of range. I felt like a number in and out... I am hoping to find the answers.
This case was reported by a non-health professional via local affiliate and described the occurrence of speech loss in a 4-month-old patient who received DTaP vaccine. Co-suspect products included Rotavirus vaccine, Hepatitis B vaccine, Poliomyelitis vaccine (IPV) and Pneumococcal vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose, Rotavirus vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose, IPV at an unknown dose and Pneumococcal Vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine, the patient experienced speech loss (serious criteria death), movements reduced (serious criteria death) and withdrawn (serious criteria death). On an unknown date, the outcome of the speech loss, movements reduced and withdrawn were fatal. The reported cause of death was speech loss, movements reduced and withdrawn. The reporter considered the speech loss, movements reduced and withdrawn to be related to DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine. Additional details were reported as follows: This report was found in a debate article published in a newspaper (there was no information about the source of the information and no contact information to the author of the debate article). The Vaccination Court believed it was proven that the patient died of vaccines. The parents visited their pediatrician with their baby vaccinated with five different vaccines. According to the court documents, the patient's physician described in his journal at the physician's visit that, the patient was healthy, cooperative, well-fed and babbling. After the physician's visit, in the afternoon, the parents noticed that the patient was no longer babbling, the patient was instead withdrawn, silent and moved less than before. Less than 24 hours later, the patient died. It was unknown if an autopsy was performed or not. The reporter considered the speech loss, movements reduced and withdrawn to be related to Poliomyelitis vaccine (IPV) and Pneumococcal vaccine as well.
Don't know lot #.   Within 15 hours of injection:  fever (100 degreees), chills, headache, pain along neck, shoulders, and face, severe nausea and vomiting, dizziness.  The strength and degree of these symptoms was well beyond what should be considered "minor side effects" of a vaccine.  I had NO side effects from the first Shingrix vaccine, given at Pharmacy, in October 2020.  This vaccine is UNSAFE.
Client presented to the vaccination site on 01/08/2022. The client notified RN that she received a first dose of Moderna on 12/11/2021 and is here for the second dose of Moderna. Per patient  develop redness in between her groin area three hours later after vaccine administration. No other symptoms were reported. Per patient applied hydrocortisone cream and redness subsided shortly area intervention. No underlying conditions, NKA and taking daily birth control were reported by patient. RN submitted a medical consult via text message to staff member, requesting to proceed with the COVID vaccine Moderna. COVID vaccine Moderna was obtained from medical consult team via text message from MD. Client received COVID vaccine Moderna Lot# 069H21A on 01/08/2022. The client did not report any symptoms during the 30 minute observation period. RN  educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1:25pm with a steady gait. VAERS completed.
Pt was a large 11years 7 month old male, was registered with correct date of birth, as under 12 years, but pt and mother went to the adult section, and subsequently received an adult (12 and over) dose of pfizer instead of the pediatric dose.  Pt's mother noted to the staff that she wanted her large for his age son to get an adult dose.  Unclear if she purposefully went to the adult area.  There was NO adverse reactions.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age who on 07-AUG-2012, was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number 670547/0659AA) that was expired. The vaccine expired on 04-AUG-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards.  In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse.  With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission.   On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
SHAKY; FEELS ON EDGE/ANXIOUS; FEELS LIKE ESSENTIAL TREMOR; JOINT PAIN; FEELS LIKE RUNNING A FEVER; DULL HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included essential tremor, fibromyalgia, and autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced shaky. On MAR-2021, the subject experienced feels on edge/anxious. On MAR-2021, the subject experienced feels like essential tremor. On MAR-2021, the subject experienced joint pain. On MAR-2021, the subject experienced feels like running a fever. On MAR-2021, the subject experienced dull headache. Laboratory data included: Body temperature (NR: not provided) 97.2. Laboratory data (dates unspecified) included: Autoimmune disorder (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from joint pain, had not recovered from dull headache, and shaky, and the outcome of feels on edge/anxious, feels like running a fever and feels like essential tremor was not reported. This report was non-serious.
delayed cutaneous hypersensitivity reaction Narrative:  Onset 3-4 days after 1st dose lasted about 4 days. Redness, itchy, size of quarter.
I started smelling and tasting a strange taste like urine and/or sulphur in the food I eat and the beverages I drink. It may be a side effect of the vaccine, since it started at nearly the same time as my second vaccine dose.
Pt recvd a series of 3 doses of Engerix-B & 6 wks following vax pt was a non responder; 4-5 months p/3rd dose pt recvd a booster dose & still did not respond;
FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient 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 10-APR-2021 for prophylactic vaccination. The Batch number was not provided and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: naproxen sodium.  On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and severe headache was not reported. This report was non-serious.
I administered the Moderna vaccine (LOT 007B21A, EXP 9/8/21) on 4/13/21 @ 2:13pm and asked the patient to remain seated in her chair for at least 15 minutes. Approximately after 5 minutes, my technician noticed that the patient was pale and immediately flagged me. I stopped what I was doing and immediately checked on the patient. She stated that she was feeling nauseas. The patient appeared to be sweating. We grabbed an ice pack and garbage can. Within approximately a minute, the patient started vomiting 3 or 4 times over a period of approximately 5 minutes. We applied cold compresses to patient's neck and face. The patient started to feel better as time progressed. Patient stated that she did not eat much for lunch (chips), felt a little anxious, and felt a little warm/hot before getting the vaccination (she had on a rain jacket). I contacted pharmacy market manager. We checked her blood pressure and it was 120/90 with 93 pulse. We stayed with the patient and comforted her. She called her husband to come pick her up. She thanked the both of us. We were very thankful that the patient was safe and never fell off her chair or injured herself. I called her about 45 minutes after she left the club to check up on her and she mentioned that she feels perfectly fine now.
No  immediate side effects.  After the second dose platelets started to drop.  Drop detected subsequent to second dose.    Got worse after third dose.   Vaccine unknown if cause.  History of low platelet count but now critical low levels.   Currently under medical care for low platelets.
Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
I developed a sore throat in mid Jan 2022 accompanied with fatigue and discomfort. After a week, I took a self-test and tested positive. At that point I was feeling really bad. I went to the Health Clinic and received an anti-body drug. I was in bed for a week with a fever, dry cough, fatigue and soreness. After another two weeks I began to feel like I was back to normal.