chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness; Heat; Redness spread below the injection site; Soreness at the injection site; she developed a rash; She was slightly tender on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), RASH (she developed a rash), MYALGIA (She was slightly tender on the arm) and VACCINATION SITE ERYTHEMA (Redness spread below the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MYALGIA (She was slightly tender on the arm). On 07-May-2021, the patient experienced RASH (she developed a rash). On an unknown date, the patient experienced PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness spread below the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved and RASH (she developed a rash) and MYALGIA (She was slightly tender on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported by the reporter. Treatment information was not reported. The patient weight reported as 130 unit was not provided. On 20 Jun 2021 Patient told that she felt almost "back to normal" by the Day 5 had no lingering symptoms.   This case was linked to MOD-2021-093330, MOD-2021-229809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Additional information was received symptoms Outcome was updated from Unknown to Recovered. On 21-Jun-2021: Follow up received on 21 June 2021: added new events Myalgia and Rash, added vaccine information patient route of administration and batch number added second dose details.
Chills, itchy, horrible burning rash in throat, short of breath, throat very red inside mouth.
Swelling, redness and pain for 6 days, followed by itching for 1 day. Entirely abated day 8. Area affected, whole upper arm.
This case was reported by a consumer and described the occurrence of lightheadedness in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (ENGERIX B, GlaxoSmithKline) for prophylaxis. On an unspecified date, the subject received an unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced lightheadedness and an out of body sensation. The reporter was the subject's mother, who refused to provide any further information, as she stated that her daughter was "of age". At the time of reporting, the outcome of the events was unspecified.
Severe reaction lasted 1 day. Same evening after receiving vaccine, patient couldn't raise arm, had severe headache and body aches. She slept for 24 hours and had no mobility in arm. After the 1st day symptoms improved slightly over the next week but still hasn't gotten completely better. Now still has some pain and lack of mobility. Nurse recommended alternative moist heat and ice and now a little better.
I woke up felling hot; I feel hot and its not hot; Shaking; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An 89-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset 21Dec2022, outcome "not recovered", described as "I woke up felling hot; I feel hot and its not hot"; TREMOR (non-serious) with onset 21Dec2022, outcome "not recovered", described as "Shaking".  Additional information: Consumer stated, "I am having a reaction to the Pfizer shot, the newest the latest one, Covid19 vaccine, bivalent one, the original one. I woke up feeling hot and I am shaking and I feel hot and its not hot."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On 5/28/21, patient presented to the ED for SOB and np cough which started 5/24. Patient states chills, subjective fevers, cough, SOB/DOE worsened over th eweek. She is on 2L O2 at home and with exertion her O2 sat would drop into the 70s.  Rapid COVID-19 is positive. Admitted with acute on chronic hypoxemic respiratory failure secondary to SARS-CoV-2 pneumonia. Completed remdesivir, cefepime, Zosyn, and azitrhomycin, receiving dexamethasone, intubated 6/1/21 for persistent respiratory failure.
After the 15 minute wait period, patient began to feel faint and weak as he was shopping in the store. He was helped to a seated position. Blood pressure was 81/61 and pulse 108. He felt hot and vomited a small amount.
#2 days after receiving vaccination, At 7a this morning, nocticed "hives": Neck itching not on back or stomach. Red splotches with some raised spots: All over entire back up to base of neck, creeps around as if wearing a scarf to the sides of neck and down front of shoulders and front of trunk. On trunk/stomach, starts under bra line and goes down.
constant dizzy spells and lightheadness. This never happened prior to the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Oct2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 11Oct2021, the patient experienced constant dizzy spells and lightheadness which had never happened prior to the vaccine administration. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant dizzy spells and lightheadness were not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Nov2021 at 11:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first time (3/6/21), my arm was hurting later that evening. It happened the same way on 4/2/21, but much worse.  I got up the next morning, and I was ok besides feeling the pain in the arm.  Later that afternoon, I had flu-like symptoms.  The site was red and swollen, and for a few days the site was itchy, red,  and it had gotten bigger.  While I was visiting store pharmacy, I asked the pharmacist about what  I needed to do about the itching and she told me to use Benadryl.  That helped.  It took a full week for my arm to stop hurting and for the knot to go down along with the itching.  I was on spring break when all of this was going on.  When I went back to work this past week, my left arm was hurting so bad, I felt as if I could not do my work.  I took two ibuprofens, and I went to see the school nurse about a heating pad.  She gave me a clay pack to put on my arm.  It felt like a bad tooth ache.  The pain was terrible for all last week, and I used a heating pad to relieve myself of the pain.  I contacted Dr. on 4/14/21 about the pain I was experiencing, and she told me to use the Meloxicam she prescribed to me in February.  I've had to use a pain creme to help with the pain.  My arm was hurting before I had the second shot, but I was never in pain like this until after I had the second shot.  I am only reporting because I had pain, swelling, itching at the site, as well as, the excruciating pain that was in my shoulder and arm for days.  Today (4/18/21), the pain is slowing down.
chills; sweating; very bad cold; very weak; lethargic; not feeling well; wasn't feeling good; sick; Little pain in my arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EL9267) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (Lot number: EL9263 as dose 1, single), administration date: 25Jan2021, when the patient was 86 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Little pain in my arms"; CHILLS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sweating"; NASOPHARYNGITIS (non-serious) with onset 26Feb2021, outcome "unknown", described as "very bad cold"; ASTHENIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "very weak"; LETHARGY (non-serious) with onset 26Feb2021, outcome "unknown", described as "lethargic"; MALAISE (non-serious) with onset 26Feb2021, outcome "unknown", described as "not feeling well; wasn't feeling good"; ILLNESS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sick". The events "little pain in my arms", "chills", "sweating", "very bad cold", "very weak", "lethargic", "not feeling well; wasn't feeling good" and "sick" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient took the first dose and she was fine. It was reported that patient was fine, she had a little pain in her arms and it went away in about two days. Four days after the vaccination, patient came down with chills, no fever, then sweating and it was like a very bad cold and very weak and lethargic and just not feeling well, 4 days after patient was still sick. The patient went to an urgent visit. It was reported that it was not worsened but she was still sick, have chills and sweating. Patient called her doctor and asked if she should come in today and he said it's a reaction to the vaccine just take paracetamol (TYLENOL).   No follow-up attempts are possible. No further information is expected.
Achy; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix.  Additional details were privided as follows: The reporter reported that, the patient was around 62 years old. The age at vaccination was not reported. The pharmacist reported that, the patient experienced pain and influenza like symptoms for 1 week after dose of Shingrix. The reporter reported that, the patient was due for the 2nd dose opf Shingrix, but did not want to get because opf adverse effect experienced after 1st dose. The responsible physician's information, any details regarding vaccine, and any further details regarding the event were unknown. The reporter did not consent to follow up.
2 events. The day after (mildly) and the next 1.5 days, more intensely, I had significant flu like symptoms including skin sensitivity, reduced hand strength, shivering, general malaise and feeling horrible. This by itself would not have precipitated this report. The reason for this report is that I went to my doctor today for a 2-3 week significant and very itchy rash on my upper left thigh which he immediately diagnosed as shingles, not knowing ahead of time that I had received the Shingrix vaccination a month prior. So it would appear that within 2 weeks or so of receiving the vaccination, I developed shingles.
Chills and hot/cold started evening of 6th day post-dose. Morning of 7th day post-dose woke up with headache, fever, chills, muscle aches (neck/shoulder and lower back), and nausea which persisted throughout the day. Max temp was measured as 101.0°F.  Morning of 8th day post-dose woke up with a mild headache, fatigue, and lack of appetite. Morning of 9th day post-dose woke up with a headache that resolved by midday. No pain relievers or medication were taken.
Pediarix and Engerix-B on the same day; This case was reported by a physician via call center representative and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number 25n35, expiry date 16th March 2025) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022002098  Additional details were reported as follows: The reporter was a Pediatrician. The patient was inadvertently administrated Pediarix and Engerix-B on the same day, which led to overdose. The reporter consented to follow up.
stroke; feeling exhausted; problems with her eye after the stroke; threw up everything/ vomiting; fever; diarrhea; no energy; dizzy; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Common variable immunodeficiency. Concomitant products included ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 02-May-2021 at 10:20 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 03-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhea), ASTHENIA (no energy), VOMITING (threw up everything/ vomiting) and PYREXIA (fever). On 04-May-2021, the patient experienced EYE DISORDER (problems with her eye after the stroke). On 07-May-2021, the patient experienced FATIGUE (feeling exhausted). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DIARRHOEA (diarrhea), ASTHENIA (no energy) and VOMITING (threw up everything/ vomiting) outcome was unknown and DIZZINESS (dizzy), EYE DISORDER (problems with her eye after the stroke), NAUSEA (nauseous), PYREXIA (fever) and FATIGUE (feeling exhausted) had not resolved.            Patient gets Immunoglobin infusion for autoimmune disease Common variable immunodeficiency (CVID). At the hospital patient was treated with intravenous medication, blood thinners and she took Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-106750 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from an immunization program refers an patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (route, site, dose, strength not reported, lot # H021861, exp. date: 09-OCT-2015). Follow up information received from the nurse. The patient had been revaccinated. No symptoms reported. This is one of several reports received from the same source. Additional information is not expected.
She had the worst migraine of her life a few days after the vaccine.  She reports continuing to have pressure in her head since that time.  She also complains of numbness of both hands with pins and needles sensation, and she has an electric feeling in her legs, like a popping sensation.
CLOT OF ABOUT 3-4 INCHES; LOWER LEG PAIN; This spontaneous report received from a patient via a company representative concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient had no history of blood clots and is active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced lower leg pain. About a week after that, on an unspecified date in 2021, the patient experienced clot of about 3-4 inches confirmed by ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lower leg pain and clot of about 3-4 inches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 35-year-old male patient of unknown ethnicity was reported in social media to have "clot of about 3-4 inches confirmed by ultrasound" after an unspecified duration from receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  This was preceded by symptom of lower leg pain 1 week prior.  No other details was reported.  The information available precludes a complete and meaningful assessment. The case will be re-assessed once additional information is received.
nauseated; vomiting anytime she attempted to eat a meal; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes and Thyroid disorder NOS.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal). At the time of the report, NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 10 (High) elevated blood sugars of "10".     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient visited her primary care physician and was prescribed unspecified additional medication for the elevated blood sugar.
pt had inject 11AM Tues & mom noticed rash, Wed Am; pt had soreness around inject area & rash down from site; was itchy; pt did have sl loss of appetite; no fever; given DPH for itching; taken to see MD; pt had red ear;
Patient was scheduled for a Pfizer Primary dose but was instead given Pfizer Booster Bivalent Adult dose his left deltoid.
Around 9:50 AM patient received a flu shot and then her son received one. One to two minutes later after she received her shot, the patient felt dizzy and flush. I had the patient sit in a chair and propped the patient's feet up in another chair. The patient never had any breathing or vision problems. I gave her a bottle of water and employee fanned her with plastic blue cards. I got another employee to activate the ice packet and get it to working. The patient put the ice pack on her forehead. I had someone else call the switch board 129 for a code white and for a member of management. The patient requested us to call an ambulance. Talked to 911 and then to the ambulance service but then while on the phone with ambulance service the patient changed her mind and canceled the ambulance request. The patient kept feeling a little better and a little better. Manager filled out a report on the Ipad and I filled out a section as a witness. The patient left at 10:12 AM.
Left arm became erythematous, edematous & warm to the touch. No pain. The vaccine was given in the right arm. This was approximately 4 hours after the vaccine was given. Patient states this has happened before with other vaccines due to a history of breast cancer and lymph node removal.
L upper arm-irregular red, warm patch & mod. increase COPD related wheezes.