chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bright yellow rash or bruising lasting for a few hours on non-vaccinated arm; Vaccinated arm significantly colder than the other arm; Numbing of vaccinated right arm, then right leg, then left leg hour; This is a spontaneous report from a contactable consumer, the patient. A 24-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 right arm on 16Apr2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications included levonorgestrel (MIRENA) from an unknown date taken for birth control. Prior to the vaccination, it was unsure if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 21Apr2021, the patient underwent PCR test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced numbing of vaccinated right arm, then right leg, then left leg hour after vaccination for several hours after vaccination. Next day (17Apr2021), vaccinated arm significantly colder than the other arm. On 04May2021, the patient experienced bright yellow rash or bruising lasting for a few hours on non-vaccinated arm. The clinical outcome of the events of numbness and coldness  was recovered on an unknown date in Apr2021 while the clinical outcome of the event of bruising of arm was recovered on 04May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
One week exactly after shot I had an allergic reaction on my arm.  My upper arm got very red and itchy .. using benedryl and allergies has helped calm it down
Patient states received Tdap in left arm on 6/5/2015, began to have fever that night that resolved 6/9/2015.  States fever ran from 39-40 degrees Celsius.  Took medicine but was not able to sleep well due to fever.  6/8/2015 began to have redness and swelling in arm.  States injection site from a childhood vaccine was also hard and red, which has never happened before.  States both new and old injection sites were painful.  On 6/10/2015 states most recent injection site is hard and painful.  Old injection site is red, painful, swollen.  Denies itching.  States entire upper arm, from shoulder to elbow, feels hard.  States she does not feel feverish today.  Current temperature is 98.2 degrees Fahrenheit.  Upon examination, newest injection site appears asymptomatic, but has small induration noted on palpation.  Site where patient states she had injection as a child is reddened, raised, and feels hard.  Patient winces upon palpation of both sites.  States each day, pain and hardness seems to progress further down arm.  Referred to Dr. and given acetaminophen to take at home and instructed on use.
Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Vomiting-Medium
All of the following symptoms have lasted for 3 weeks and 1 day. Severe fatigue Headache Stomach pain Fever 99.5 to 102.5 Painful joints, especially knees New back pain Brain fog First ever episode of Afib As I stated, all of these symptoms have lasted 3 weeks
Moderna Covid-19 Vaccine EUA  I had an immediate headache and metallic taste in my mouth within 1 hour of the vaccine. Those symptoms went away within 1-1/2 hours of the vaccine. Then on Saturday morning at 2am I developed chills, body and joint ache diffusely. I took 600 mg of ibuprofen at that time and they symptoms were gone by Saturday morning at 9:30am.
Aching joints, headache,swelling at injection site, orangish discharge from injection site, can not stay awake, red bloodshot eyes body aching, arm extremely painful to move.
17 YEAR OLD PATIENT WAS ADMINISTERED MODERNA COVID-19 VACCINE IN ERROR
1.First dose 01-20-21 gave me dizziness and nausea for half an hour. I did not go to the doctor 2. second dose 02-10-21 the entire left side felt cold, like when they put ice in that area. This happen for an hour and a half. I did not go to the doctor. 3. Third dose 10-16-21 a lot of pain in the back and joints. sometimes my skin burns, my blood  pressure is altered. I have not reported this to my doctor.
No side effects 1st shot but slight headach; severe chills; Fever; lack of energy; hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Nov2020, stop date: Nov2020, notes: in November of 2020; "chronic obstructive pulmonary disease", start date: 2015 (ongoing), notes: 2015 and ongoing; "non-tobacco user", start date: 2015 (ongoing), notes: 2015 and ongoing; "sinus headache" (ongoing), notes: ongoing sinus headache teen/adult all my life/Ongoing. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "No side effects 1st shot but slight headach"; CHILLS (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "Fever"; ASTHENIA (non-serious) with onset 08Feb2021 23:00, outcome "recovered", described as "lack of energy"; ALOPECIA (non-serious) with onset Feb2021, outcome "recovering", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: (To update patient details, suspect product details, events and lead line of narrative.)
My daughter reported severe pain (for someone who has a very high tolerance for pain) as soon as immunization was administered. She then felt dizziness/light-headed, stepping down from the examining table. While exiting the clinic through the triage area, her lips turned pale, then her face. My daughter then sat down on a chair while I went to get help; a nurse came. Patient (my daughter) had her eyes closed and almost slid from chair, she briefly open her eyes and sat up on chair again, closing her eyes. Nurse asked her to open her eyes, she responded "I can't." Patient lost consciousness and slid from chair. I tried to get closer to catch her when she suddenly began to have some jerking movements, like a seizure. I ran  to the hallway, screaming for more help, and immediately returned to my daughter whom I found on the floor, still having some jerking movements. After a few seconds she stopped moving, as if she went to sleep. Nurse checked her vital signs and blood sugar level. Patient woke up, confused, wondering what she was doing on the floor and where one of her shoes was (she had kicked it off while having jerking movements). A doctor then asked her name and date of birth; she responded appropriately. She was given a pillow for the head, and a popsicle to eat, then was moved to a seated position (on the floor still). Another doctor gave her a vegetable sandwich, she ate it, reported feeling better, waited a few minutes sitting down and slowly stood up and left in stable condition, but still hurting from immunization. No complains up until today, except for pain on upper right arm where vaccine was administered.
MIGRAINE; SORE ARM; NAUSEA ON AND OFF; FATIGUE; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. 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: Unknown) dose, start therapy date were not reported 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, the subject experienced migraine, sore arm, nausea on and off, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, sore arm, nausea on and off, and fatigue. This report was non-serious.
I experienced severe chills, fever of 102, extremely swollen and hard lymph node in my left arm pit, coughing, purple rash all over different parts of my body.
Patient received one dose Hepatitis A vaccine inactivated. Pt developed hives,sought unspecified medical attention. "most allergy tests were normal" Pt's hives persisted.
Within 6 hours of the injection, I experienced a severe headache, 101-degree fever, chills, severe leg pain, and fainting spells when attempting to walk.  The symptoms lasted approximately 24-hours.
After receiving the vaccines, the patient reported her throat feeling tight and her tongue was tingling.  She was having difficulty speaking. We discussed that she might be having an anaphylactic reaction, and the pharmacist and patient agreed to administer an 0.3mg epinephrine injection.  The patient reported feeling much better shortly after. A team member called 911 and the patient refused follow up care.
Pt was diagnosed with COVID at Urgent Care the day prior to admission to Labor and Delivery. She is 39 weeks and 6/7 days with active contractions.  She complains of congestion, non-productive cough, and very mild rhonchi in the upper lobes.
15 minutes after vaccination the patient noted they "felt like crap." The patient's wife is an EMT and called her boss who came as an emergency service and they denied all interventions I offered at the time. They did allow me to check temperature and pulse oxygen level. EMS arrived and took the patient away.
UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received their initial vaccination with covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose series 1) (suspension for injection, route of admin, batch number, and expiry date were not reported) dose, start therapy date were not reported, administered for prophylactic vaccination. No adverse events were reported  (dose series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 18-NOV-2021 on left arm at 11:30 am for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced unexpected benefit (dose series 2). He reported that his peripheral neuropathy went away, there was no tingling, sharp pains out of no where, no numbness or cramping in feet. His feet felt great and were still feeling great at the time of reporting.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.
After receiving vaccinations, my son was developing a fever at 102 degree at that night.  I treated him tylenol infants' drop 0.6ML at 8:30pm.  After one hour, his fever was not decreased.  I called his doctor and was advised to treat him tylenol again after 4 hours.  Around 10pm, my son was getting so weak, vomit, moaning and febrile convulsion.  He was taking his second tylenol at 12:30am.  In the next morning, he had low-grade fever and no appetite.
2 hours post vax pt developed a headache, fever of 102F, aches and pains and chest tightness. Pt was treated with Benadryl, Demoral and Phenergan.
12/29/2020 2 hr after vaccination patient became hypotensive, decreased oxygen levels was transferred to Hospital currently inpatient at hospital - admitted for cardiac arrest
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with the ZOSTAVAX administration site. The patient complained that it really bother her for about 7 days. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304935, 2018SA304936 and 2018SA304935. This case involves 82 years old female patient who was vaccinated with 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI842AB, expiration date:04 Apr 2018) via intramuscular route in left upper arm on 15-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired product administered. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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
Client received first dose Moderna vaccine at 1400. Has allergy history so was asked to wait 30 minutes post vaccination. At 1435 client complained of feeling dizzy, mouth and tongue were feeling swollen.  BP 160/110 P 115, 02 sat96%, Sat with client and monitored vitals. Cool compress applied to head. Client drank some juice and ate some crackers. Continued to improve and left without an escort at 1600.  Vitals were 150/70, P 92, 02 sat 98%.
Consistent insomnia since 7/19/2021, regardless of medication  nausea and vomiting from 7/20/2021-08/13/2021, regardless of medication.  Body chills on left side of body (injected side) 7/21/2021-current 08/17/2021 significant mood changes 07/20/2021-08/15/2021
Concerning reactions; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Concerning reactions) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (Concerning reactions). At the time of the report, VACCINATION COMPLICATION (Concerning reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment details were provided.    This case was linked to MOD-2022-452812, MOD-2022-452775 (Patient Link).
Vaccine given on Feb 5th in right arm.  At first some slight soreness at injection site. On Feb 12th, exactly 7 days after vaccination, the injection site became itchy, and around the injection site a slight rash developed. It is now February 14th and the itchyness and rash seem to be subsiding. I have applied Aspercreme to the site and took a 25mg Benadryl, and there have been no further complications
Initial report was received from a health care professional through an affiliate on 30 May 2012 under local reference number 1-380197298. A patient (age, date of birth and gender not reported) had received a dose of RABIES VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later the patient experienced an anaphylactic reaction. The patient also had an anaphylactic reaction to MMR vaccine. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
hot at the injection site; hard at the injection site; red at the injection site; Fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving the vaccine).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive had COVID before receiving the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
General Body pain; Hot injection site; Itchy injection site; Redness at injection site; Joint ache; Headache; Nausea; Fever (101.9); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and ARTHRALGIA (Joint ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)). On an unknown date, the patient experienced PAIN (General Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)) outcome was unknown.            No Concomitant medication were reported.; 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.
1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.
This morning, father noted redness and swelling of the right thigh and stated, "looks like a mosquito bite". He also stated, "he complains of pain once in a while but walks without difficulty. No itching, no fever noted. Denies any other signs and symptoms. Father called clinic to report this incident.
1st day sore arm. Symptoms increase in following days very weak, nausea coughing unable to keep shoes on low blood pressure high. Heart rate, fever 103, urinary tract infection. Hospitalized 4 days on IV antibiotics.
The patient's past medical history included Fertility decreased (only indication for low fertility is age and took intrauterine insemination as fertility treatment on Jun-2017 twice.), Alcohol use (occassional) on 13-Nov-2020, Nicotine abuse (1 pack/week) on 01-Dec-2003 and Induced abortion (1 elective abortion 20 years ago.) on 13-May-2001. Previously administered products included for an unreported indication: MARIJUANA until 01-Aug-1999. Family history included Down's syndrome (Down's syndrome - maternal uncle) since an unknown date. Concomitant products included GLYBURIDE from 23-Apr-2021 to an unknown date for Gestational diabetes mellitus, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 26-Dec-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 14-Feb-2021 to an unknown date for Pregnancy.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (7 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (7 weeks pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Pregnancy test: positive (Positive) positive. On 04-Jan-2021, Ultrasound uterus: 1-fetus (normal) Pregnancy confirmation ultrasound. 1-fetus. In March 2021, Alpha 1 foetoprotein: normal (normal) normal. On 24-May-2021, Ultrasound uterus: normal (normal) Normal. On 04-Jun-2021, Glucose tolerance test: abnormal (abnormal) abnormal.         Treatment information was not provided.  The estimated date of conception was reported as 20-Nov-2020. The patient had maternal history of subfertility due to age and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Added concomitant drug, lab data and 2nd dose of Moderna, history added, due date updated, positive pregnancy date updated.; Reporter's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.