chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Shortly after I got the Covid shot, I started having very bad headaches, upper back ache and general body aches. I started to have a sore arm and raised rash area. I took Benadryl, but this did not help the rash. The next morning the backache had dulled, but the headache and rash were still there. After 1 week the rash started to become a cherry color, become very hot and was in the shape of the number five. I have photos, and also showed my manager. Due to me working for a home care company, and due to being mandated to get the shot or terminated, it was not an option for me to get a medical exclusion as they were not being accepted. By the end of second week after my vaccination the cherry color started to subside and the heat had gone away, but this was a two week timeframe. When I got the second Moderna Covid 19 vaccine on 11/22/21, I started to have headaches, back pain joint pain and nausea within 3 hours. That night the overall body aches, muscle and joint pain and headache were very severe, but the nausea had subsided. I called in sick to work. By morning I was in severe pain, sweating, not sure of the fever temp, had terrible muscle and joint pain. By 9 am or so I was in so much pain and felt so bad I asked my husband to either take me to the hospital or give me something to knock me out. He gave me a Motrin 600 and an old Vicodin, and a heated up bean bag to stop the muscle pain in my back. I woke 4 hours later so completely drenched in sweat, you could have literally run me out. I was dizzy, had severe brain fog and had trouble standing. The bed was completely soaked down to the mattress. It took another full day of sleep and another week before I started to feel normal again.
03/14/05: Per mother patient became fussy, weepy, tired, within 30 minutes of vaccinations. She had decreased appetite and increased sleeping on the 11th, 12th 13th and 14ht; vomited once on the 14th. No fever. Called PCP who referred mom to health department. 03/15/05 telephone call to mom, who reports child improving, will not follow up with PCP. Had 3 grand mal seizures at age 1, not related to vaccine. No medications given. No seizures since then, mom reported this on 03/11/05 on questionairre.
Memory loss & confusion (forgot door code and could not remember how to process work transactions, after doing them for several years); Memory loss & confusion (forgot door code and could not remember how to process work transactions, after doing them for several years); Significant and pronounced joint & muscle pain; Significant and pronounced joint & muscle pain; Diarrhea; Slight fever; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 23Aug2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no and 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 take any concomitant medications. On 24Aug2021 at 01:00 the patient experienced memory loss & confusion (forgot door code and could not remember how to process work transactions, after doing them for several years), significant and pronounced joint & muscle pain, diarrhea and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss & confusion (forgot door code and could not remember how to process work transactions, after doing them for several years), significant and pronounced joint & muscle pain, diarrhea and slight fever were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a female patient of unknown age concerning herself. Information about patient's medical history was not provided. On 20-MAR-2015, the patient was vaccinated with a fourth dose of M-M-R II (therapy type, dose, frequency, route of administration and lot # were not reported), because her titer was seronegative after 3 previous doses of M-M-R II (date of laboratory test unspecified). No concomitant medication was reported. No treatment was given for adverse event. No additional laboratory tests were performed. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The outcome of the evert was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
patient of 15 years old was administered with a Flublok, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was vaccinated with a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination on an 26-Sep-2020PT (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  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 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.
Patient received Moderna COVID vaccine on 1/20/2021. Shortly after (with in 1 week) patient experienced addominal pain, diarrhea, loss of appetite, and chills.
Pain in hips and knees with stiffness of joints. Used Tylenol for pain relief.
Left arm sore in the evening after vaccination, next day stiff and unable to lift arm above shoulder.  Remained sore for next week.  Small, red, pin-point spots around injection site appeared.  Stayed a few days.  They were itchy.  Spots have subsided.  Injection needle site still apparent on arm with a small scab.  12/7- states he awoke to a quarter size amount of serous fluid on bed sheet.  Wife touched area and more serous fluid came out.  There appears to be two yellow colored aged bruises that are dime sized below the injection site.
My (left) elbow started to swell on Wed the appearance was of a access not too big. The next day on Thursday morning my elbow was the size of a lemon. I went to the doctor on Thursday evening by that time it was size of a orange was prescribed Sulfamethoxazole twice day 10 days and referred to Orthopedic Surgeon 7/30 due to size of the swelling on my elbow.The Orthopedic Surgeon stated my bone looked fine just had some infection. I revisited the Orthopedic Surgeon on 8/3 for follow up and as of today the swelling has gradually went down.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 31 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
19APR96 mom brought pt in rt leg was swollen, reddened, hot & had area of discoloration @ center of circumferential area;area 3" by >3inches w/tan coloration;rim of swollen area was bright red, 7/8 of hot, firm area was tan discoloration;
Swollen left armpit; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, expiration date not reported), via an unspecified route of administration, administered in the left arm on 13Mar2021 09:30 (at the age of 33-years-old), as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, expiration date not reported), via an unspecified route of administration, administered in the left arm on 20Feb2021 (at the age of 33-years-old), as first dose, single dose for COVID-19 immunisation. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced swollen left armpit on 13Mar2021 21:00 (reported as starting about 12 hours post vaccine). No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I tested positive for COVID-19 on 12/15/22.  I had a fever, chills, body aches, and a scratchy throat. I contacted my doctor and was prescribed 5 days' worth of Paxlovid. I am still dealing with my symptoms. They aren't as bad, but I still have them.
Extreme muscle pain and slight headache which was gone by 3/18/2021.  Hurt to even turn head.  Spike in blood pressure on 3/18/2021 to 191/91.  Returned to 152/71 on 3/19/2021.
09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Patient had fever within 7 hours of injections, elevated heart rate averaging 130bpm for 5 days as monitored by his smart watch, and 36 hours of insomnia following the injections
Case number PHEH2013US021754 is an initial spontaneous report from pharmacist received on 17 OCT 2013 with a follow up received on 17 DEC 2013. This case refers to a 60 year old female patient. Her vaccination history included administration of flu vaccines in the past that were tolerated well. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309401, expiry date: APR 2014) at 0.5 ml intramuscularly into right deltoid on 16 OCT 2013. The pharmacist stated that she received FLUVIRIN that had been pre-drawn from multidose vial, held out for approximately 15 minutes and then administered. The seriousness and causality of event was not reported. No adverse event was reported due to medication error.  Follow-up was received from the pharmacist on 17 DEC 2013: Updated vaccination history of the patient and site of administration of FLUVIRIN.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On an unknown date in 2012 (reported as 3 years ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot number was not reported). Concomitant medications was not reported. On an unknown date, the patient was inadvertently vaccinated with second dose of ZOSTAVAX (dose, route and lot number was not reported). No adverse effects was reported. No further details provided. Additional information has been requested.
SHINGLES, LASTED ABOUT A WEEK. SORE LEFT ARM WITH LIMITED MOVEMENT AND STILL SORE 4 SEEKS AFTER 1ST SHOT.
Inflammatory nodule that is red and tender to the touch. Had it cultured at the lab on 10/26/2018 and came back on 10/30/2018 as no bacteria growth.
Pt received Moderna COVID vaccine at 0850. RN responded when pt c/o dizziness at 0905 while sitting in observation area. Pt pink, warm and dry. RR easy and regular. Radial pulse 100, BP 174/108. Pt stated she took her morning meds including antihypertensives this am at 0800 on an empty stomach and then did not eat breakfast. Pt given water to hydrate and crackers. At 0910 pt denied dizziness. At 0910 BP 200/76 and pt stated I feel better.  Both nurses remained with pt at all times. At 0918 BP 208/88. Pt encouraged to go to ER or her PCP for further evaluation. Pt's niece was in attendance and made an appt with pt to go to her PCP  at 1215 today. At 0930 pt stood and ambulated and stated she felt fine to go to her doctor.  Pt escorted by wheelchair to her car per volunteer staff. Pt discharged with her niece in attendance.
Left thigh red swollen with clear blisters. Warm compresses 1gm Rocephin.
Nasal congestion; Swelling of lips; This is a spontaneous report from a non-contactable consumer, the patient. A 39-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 on an unknown date (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. It was unknown whether the patient received any medication within two weeks of vaccination. On an unknown date, the patient experienced nasal congestion and swelling of lips. The events resulted in emergency room/department visit or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events nasal congestion and swelling of lips was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she really had was a sore arm each time she got the injection.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 013L20A and 026L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.). At the time of the report, PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient had received two shots of Pfizer and most recent shot was on Sep-2022 and received Pfizer booster on Feb-2022 and was very careful had not gotten COVID yet. It was reported that patient had some filler injections two weeks ago around her mouth and on Friday last week, started getting hives right around the area where patient got the injections. Patient said that they were like hard bumps with little white heads on them and very itchy. Patient was not sure if it was some kind of allergic reaction to the filler injection. Patient received it from dermatologist and it was an injection called Juvederm. No treatment information was provided.
Information has been received from a consumer concerning his wife with arthritis who on 03-SEP-2009 was vaccinated with ZOSTAVAX (Merck). In early December 2009, the patient developed a rash on her arm, legs, and forehead. Her skin biopsy results stated "Connective tissue disease like Lupus". The patient sought unspecified medical attention. At the time of the report, the patient did not recover from these events. Upon internal review, "Connective tissue disease like Lupus" was determined to be an other important medical event. Additional information is not expected.
One week post vaccine right deltoid red, inflamed,warm to touch and itching. No treatment
THIS WAS A FIRST DOSE OF PEDIATRIC VACCINE THAT WAS ADMINISTERED 7 DAYS PAST THE MANUFACTURERS EXPIRATION DATE OF SEPTEMBER 2022 BUT STILL WITHIN THE BEYOND USE DATE OF THE VACCINE. PATIENT EXPERIENCED NO ADVERSE SYMPTOMS WE ARE AWARE OF.
Chills, fever 99.5,  nausea, diarrhea,  stomach  pain, headache
expired dose of MENACTRA was inadvertently administered with no reported AE; Initial information was received  on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult female patient who stated expired dose of menactra was inadvertently administered with no reported ae after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Mar-2023, the patient received 0.5 ml Total (once) dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (lot: U7191AA, expiry date: 18-Jan-23), (unknown strength) via intramuscular route in unknown administration site for Immunisation.  On 20-Mar-2023 the patient developed a non-serious event of expired dose of menactra was inadvertently administered with no reported ae (expired product administered) same day following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was 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 guidelines. 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.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/15/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXEMIA 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/15/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXEMIA 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/15/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXEMIA 10/28/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Left arm red and warm to touch. Left deltoid with 6 cm long X 4.5 cm wide pink macular lesion. Some slight induration centrally.
Rash at maximum- 6mm x 8mm, inflamed area, itching, 4 days then faded away.
PT RECEIVED MMR VACCINATION IN LEFT ARM ON 1/15/2008. STATED THAT ABOUT 1 WEEK POST VACCINATION, PT.'S LEFT HAND WAS FEELING SORE WITH A DULL, ACHY PAIN. THE NEXT DAY, SHE BEGAN TO FEEL THE SAME PAIN IN HER RIGHT HAND IN THE "MIDDLE JOINTS" OF HER HANDS. PT. ALSO REPORTED THAT AT ONE POINT HER KNEES WERE ACHING. RECOMMENDATION FOR PT. TO MAKE AN OFFICE VISIT TO SEE PMD.
mild mental issues; Normal side effects, feeling of anxiety; Mild mental issues, irritation; This case was reported by a consumer via interactive digital media and described the occurrence of mental disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced mental disorder, feeling anxious and irritability. On an unknown date, the outcome of the mental disorder, feeling anxious and irritability were unknown.   It was unknown if the reporter considered the mental disorder, feeling anxious and irritability to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comments: The case was reported via (Shingrix GSK) interactive digital media. The patient was received his or her Shingrix shot on Friday and experienced the normal side effects. The patient also seemed to had mild mental issues, feeling of anxiety, irritation.  The patient was asked as could this sometimes happen.
Erythema multiforme 24 hours after 4 vaccines. Also had MOTRIN dose post vaccines, prior to E.M. I have seen 2 cases of E.M. this week in clinic. Questionable viral syndrome. The child has slight rhinorrhea - mom thought allergies, dad thought URI.