chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning 8 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 26-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I went to pharmacy to receive my flu shot. I have had many flu shots before but this is different. The pharmacist seemed hurried I guess that should had been a sign but I know they were very busy that day. I went with my mother we both got shots the same day right at the same time. I felt the prick of the needle but honestly no burning I was very relaxed being I had in the past went through 10 years of depo shots, so needles don't bother me, I knew I would have some pain and burning but I kid you not this is nothing like I had ever had before. I have severe pain daily from the injection site going down my arm into my elbow and forearm including tingling numbing feeling in my fingers as well. If I lay on that arm or roll over on it in my sleep it goes completely numb and will wake me up in terrible pain. Extending my arm out or lifting any kind of weight makes it worse. Typing or using the arm hurts to the point of where I have to stop and rest it. I am going to the ER tomorrow, I just don't know what this is I think maybe she broke the needle off in my arm or something. I looked up side effects and nothing, I read where most injection site pain ends in three days, it's been far longer than that and hasn't gotten any better at all, and lifting is a huge part of my job. Without lifting I can't work, no work = no money. I mean this is just crazy and I'm tired of the pain and want to get better.
17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite.   44 hours post vax - felt better and decided to take a shower. Felt faint in the shower. Returned to bed and went into a full body cramp. My arms, hands, legs, feet all went into a severe cramp. My husband was unable to extend my arms or get my fingers to unfurl. I was in extreme pain. My lips started tingling and my word started slurring. My husband called 911.   I was diagnosed with dehydration and low potassium. My potassium was 2.6  I received 3 bags or fluids. Pain meds. A potassium drip and oral potassium at the emergency room.
MODERNA ARM - itchy full body in first 24-hours; next three days red ring on arm surrounding site of injection - itchy and swollen.
swelling on face; rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on face), RASH (rash) and PRURITUS (itchy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SWELLING FACE (swelling on face), RASH (rash) and PRURITUS (itchy). At the time of the report, SWELLING FACE (swelling on face), RASH (rash) and PRURITUS (itchy) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over my back and shoulders. It got worse over next few hours and stayed with me all evening. Had a headache as well. The next morning I was 80% better and by the next morning I was fine. The pharmacist told me that most people only get sore arm and sometimes can hardly lift the arm. I had sore arm but nothing I couldn't deal with. He also said that second shot tends to make people sick. I guess I wanna be certain I should get second vaccine?! I tested positive for covid on 12/20/20 and negative on 1/8/21.
Information has been received concerning an 8 year old male student with seasonal allergies who on 1/27/97 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The patient was exposed to chicken pox from a classmate on 10/31/03. On 11/14/03, the patient broke out with chicken pox, which was reported to be a light case. The outcome was reported as recovered on 11/20/03. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or his siblings. No further information is expected.
received a positive COVID rapid test; received a positive COVID rapid test; lost sense of smell and taste; lost sense of smell and taste; felt rundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 13Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The patient has not took any other vaccine in four weeks and there were no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 29Nov2021, outcome "not recovered" and all described as "received a positive COVID rapid test"; FEELING ABNORMAL (non-serious) with onset 26Nov2021, outcome "not recovered", described as "felt rundown"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "lost sense of smell and taste". The events "received a positive covid rapid test", "received a positive covid rapid test", "felt rundown", "lost sense of smell and taste" and "lost sense of smell and taste" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, feeling abnormal, ageusia, anosmia. 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 have any known allergies. Reporter stating events as non serious.  Follow-up attempts are completed. No further information is expected.
70 min after receiving GSK FLUARIX QUADRIVALENT vaccine, pt developed swelling in arm, itching. Gave 25 mg BENADRYL. 10 min later pt. stated her throat was swelling. Pt taken to ED, given epinephrine, dexamethasone, PEPCID.
FEVER; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
soreness; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine when it came out, the patient thought she had soreness and she made sure to hydrated before and after each vaccine. The patient did believed hydration lessen and reaction symptoms. For tolerance in 2nd dose refer case US2021AMR162113.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162113:same patient/reporter - 2nd dose
I had a cough, fever (highest 101.9), constant runny nose. I had chest tightness and fatigue.
A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 1 year old female vaccinee inadvertently received Fluvirin on 10/8/03. On 10/8/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.
Inappropriate schedule of vaccine administered; Fluids for dehydration after dose 2; Legs not working; Unable to stand or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included: "Diabetes" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: TRULICITY (received within 2 weeks of vaccination). Vaccination history included: Bnt162b2 (First dose (location of injection: left arm)), administration date: 23Feb2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: DEHYDRATION (medically significant) with onset 2021, outcome "unknown", described as "Fluids for dehydration after dose 2"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Legs not working"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "Unable to stand or walk"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "fluids for dehydration after dose 2", "legs not working" and "unable to stand or walk" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dehydration. Post the vaccination, the patient has not been tested for COVID-19.  Then, on 07Dec2021 at 12:45 PM, the patient received the third dose of bnt162b2 (BNT162B2), administered in arm left, (Batch/Lot number: unknown), for covid-19 immunisation.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUN-2015 the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided).  The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-NOV-2016, the patient was treated by a physician at a medical center for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Started feeling nauseated weekend of 05/29 and pain in upper right side of abdomen. Loss of appetite, felt, fatigued  & nausea when waking up every morning, didn't have energy to exercise 1 hour a day at gym, didn't stop feeling Nausea until this week 08/08/21 this is first week I didn't have to take nausea meds, also first week did not feel fatigued, started exercising again 2 days so far. Slight right side pain when doing treadmill, but not as bad as last 2 months
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-MAY-2014, the patient was vaccinated with GARDASIL lot # J012212, expiration date 18-FEB-2016, 0.5 ml, intramuscular. No co-suspect and concomitant therapies were reported. The nurse reported that an improperly GARDASIL stored was administered. She stated that the GARDASIL was exposed to a temperature of 69F for 21 days (504 hours). she reported that the GARDASIL was administered to the patient on "day 14 of the 21 day excursion". No adverse effect reported. Additional information has been requested.
This case was reported by the mother of a consumer and described the occurrence of nausea in a 2-month-old male subject who was vaccinated with PEDIARIX. A physician or other health professional has not verified this report. Concurrent vaccination included HIB and PREVNAR both given on 29 April 2004. There were no concurrent medications. On 20 April 2004 the subject received 1st dose of PEDIARIX at 0.5 ml. On 30 April 2004, 1 day after vaccination with PEDIARIX, the subject experienced nausea and began vomiting. Additionally, his stools were not normal. He continued to vomit after every time he ate. Up to this point, the subject had been normal and followed a normal growth pattern. After receiving PEDIARIX, he stopped gaining weight because he was vomiting so much. This occurred on and off for several months. All vaccinations were stopped at that point. The subject went to see several doctors who could not find any underlying cause. Nausea and vomiting eventually resolved, abnormal stools improved, but the digestion problems continued. The subject was noted to have food allergies (which improved), one of which was a dairy allergy. He also has a sensitivity to wheat. These conditions were not known to cause a severe allergic reaction. This was a systemic reaction. A similar reaction occurred for this subject approximately four years later following vaccination with INFARIX. For information surrounding this report, refer to case number A0742478A.
no adverse event; improperly stored dose administered; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.     On 29-AUG-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), (lot # S00352, expiration date 17-OCT-2020) intramuscularly, for prophylaxis (strength, dose and frequency were not reported) (improper storage of product in use). No adverse effects reported. It was unknown if the patient received treatment for the event. It was unknown whether laboratory diagnostics were performed.  The temperature excursion was below 36 Fahrenheit (F)/2 degree Celsius (35.4F) for 27 minutes and the data logger was involved. There was no previous temperature excursion.  Lot number S00352 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA013017:
3/6/03 started with rash on face spread to chest onto arms/legs, myalgias, arthralgias, H/A (fever 102 po x 1 day 3/9/03) sore throat. 3/9/03 Ed ? allergic reaction to MMR vaccine/viral syndrome.
Within 12 hours after the vaccination pt developed sore arm, fever, chills, and headache which all lasted for about 72 hours.
injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; This is a spontaneous report from a contactable Other Health Professional(patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 06Jan2021 18:00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 07Jan2021 04:00 PM, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever. The patient did not receive any treatment. Outcome of events was recovering.
Presented to ED w/ short of breath, ill & weakP; COVID+; tx w/steroids, singulair, O2; weaned off of O2; dc'd home
with the second dose last 06Jun, she had whole back pain and with upset stomach; with the second dose last 06Jun, she had whole back pain and with upset stomach; I have diarrhea and I couldn't eat, I am just in bed for about 6 weeks; I have diarrhea and I couldn't eat, I am just in bed for about 6 weeks; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional via Pfizer-sponsored program  Support. A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:15 (Batch/Lot number was not reported) as single dose (at the age of 70-year-old) for covid-19 immunization. Medical history included Hypertension, Bad kidney, Bad lungs, Bad Heart and Bad liver from an unknown date and unknown if ongoing. Patient took about 17 pills a day. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 11:00 (at the age of 70-year-old) as dose 1, single for covid-19 immunization and experienced headache and very sore shoulder and neck. The patient did not take other vaccines 4 weeks prior to Covid19 vaccine. No family history. On 06Jun2021, the patient experienced whole back pain and with upset stomach. On an unspecified date in 2021, patient experienced diarrhea and couldn't eat, I am just in bed for about 6 weeks. Therapeutic measures were taken as a result of upset stomach (abdominal discomfort) included Alka-Seltzer. The outcome of the events was resolved on an unspecified date in 2021 (as reported; it's just about all gone).  Information about lot/batch number cannot be obtained. No further information expected.
Very sore arm just a few hours after injection.  Injection site became very red approx. 4" all around site.  Had a terrible time trying to sleep - felt agitation and sleeplessness.  Got headache around midnight that only got worse as the night progressed.  Got up at 3 a.m. with horrible headache and lethargy.  Within a couple of hours (around 5 a.m.) started getting terrible chills to the point of visible shivering.  Took temperature which was around 100 degrees.  Within two more hours, severe nausea occurred and body temperature spiked to 102 degrees.  Myalgia in muscles from left arm stretched across upper back clear into right arm and shoulder.  My eyes burned and hurt, breathing was rapid and dizziness occurred.  Tried to lay down to sleep but, again, could not sleep.  Very restless feeling.  Took 600 MG Ibuprofen at 7:00 p.m. and fever was just over 101 degrees.  By 1:00 a.m. fever was gone.  Next day still have lingering headache, same fairly large red ring around injection site and lethargy but definite improvement from previous day.
Moderna COVID-19 Vaccine EUA:  patient presented to emergency department with dyspnea after blood transfusion for anemia. Admitted for volume overload, placed on oxygen, and dialyzed with symptom resolution. Discharged to home medically stable.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 30-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
sx started, stated two negative rapid test, positive 1/19 with Molecular, sx runny nose, congestion
About 5hours after shot, explosive diariha(shits), vomiting and nausia.  Could not eat for 2 days, I drank water and sometimes even that came back up.  also area from shot site, a huge knot formed and the knot is still there today.  I have also had bad headaches, sometime to the point to where i think my head will explode. I do not know all the other information that is required to fill out this form, I was refered to this website, by my BDE Commanding Doctor.
10/18/05 Within 2 hours of the shot, left eyelid was pinkish at eye lashes and swollen under eye. Bridge of nose was swollen, red, tender. Took Benadryl 50mg that night. Took Claritin D during the day with ASA, Motrin, and Benadryl 25mg last night and Claritin D, ASA and Motrin today. Also have bad headache.
After the vaccine I had mild nausea and fatigue. The next day my face started to have red blotches, which my whole face became red under my eyes everywhere. This was like a hot and burning feel, and I could feel that my eyes was tight. This went from my neck down into my collarbone. The injection site became sore for about a day.  My face progressed to the fact it started to peel and flake, my eyelids and under my skin. When my face started peeling it felt very like leather. I was prescribed Benadryl to take every 6 hours.  The next day after Benadryl I was given a Medrol Pack. This medication lasted for about 6 days, this helped but my face was still peeling. My eyebrows were flaking off and my eyelashes was falling off. I could not put anything on my face except water and when I did this it also look like my face was burnt.