chrisvoncsefalvay/vaers-outcomes huggingface dataset:
April 4 - awoke at 1:00 am w/uncontrollable shivering, fever, nausea, vomiting, body aches, headache.   April 5 - continued fever, nausea, vomiting, body aches, headache, difficulty walking due to pain.  Severe rash on arms and thighs. Had to use a cane to assist with walking. Went to urgent care at 9:00 pm. took Flu and 2 covid tests.  Flu and rapid test were negative. Urine sample showed bacteria and was given prescription for Keflex.  Was told I may have contracted covid prior to receiving vaccine.  April 6 - Woke up in the a.m. with severe body aches and pains all over and could not get out of bed without assistance, could not undress or dress myself. Had to be lifted downstairs in a wheel chair.  Went to ER at 9:00 a.m.  Was diagnosed with serum sickness, having a severe rare reaction to the vaccine. Was kept in the ER all day and admitted to hospital around 3:00 am on 4/7.
Large swollen hard feverish lump at site of injection. Margins kept getting larger. Gave Benadryl and the swelling began to go down.
Information has been received from a consumer refers to his current 20 year old male grandson. No relevant history was reported. In 1995, the patient was vaccinated with M-M-R II (dose, route and lot number not provided) for vaccine. On an unknown date the patient experienced autism. The outcome of autism was unknown. This is one of several reports received from the same source. The other report is 1502USA002550. Additional information is not expected as no contact information.
Sweaty and clammy immediately after vaccine on 10/7/16. 10/11/16 he developed nausea, headache, vomited x 1.
Date and time of vaccination: (list both if they received both shots):  1/5/21 1st, 2/2/21 second  Facility name where the vaccine was given.  dizziness 3 days after the 2nd shot, resolving .
Developed raised purpuric lesions on lower extremities 3-4 days after receiving Hep B #1 and PPD placement through another provider. Lesions spread to trunk and upper extremities. Biopsy confirmed HSP/hypersensitivity vasculitis. No other meds/exposure prior to onset.  Medical Record received on 12/15/2004 states pt experienced cellulitis, open leg wounds, bacterial infection, leukocytosis, leg edema and erythema legs. Follow up 02/07/05: Extensive vasculitis lesions (Hypersensitvity vasculitis of the adult) in lower extremities. In differnt stages of recovery. One of the lesions in the posterior thigh got infected with an abcess, that required surgical drainage. As per annual follow up report Patient moved no longer her provider.
4/14/21  1:20 pmSoreness around area of injection. Fatigue, mild headache. 3 pm took 1 aleve 11:30 pm legs started aching, moderate headache, took 1 aleve. 4/15/21  1:30 am, chills, legs, hips and back ache badly, moderate headache. 5am took 1 aleve, hot shower, enough relief to sleep. Temp 98.7, after shower. Mild nausea.  10 am Leg and hips still ache, but not as severe, mild headache and nausea. Temp 10 4 pm. Temp 98.6, leg and hip aches moderate, mild headache and nausea. Fatigue, slept a lot 4/16/21. 8am normal
On 6/5/01 at 13:00, the pt received his 3rd left thigh dose of Engerix-B and a left thigh dose of Prevnar. One hour, post vax, at 14:00, the mother called and stated that the vaccinee was vomiting "uncontrollably" and was very lethargic, clammy and pale. The pt was seen in the doctor's office at 15:00 and kept for observation until 20:00. During this 5 hour period, the pt continued to vomit until approx. 19:30. Small amounts of fluid (NOS) were given to the child and tolerated by him. The pt remained lethargic, clammy and pale for approx. the 1st 4 hours of observation. No limb edema, redness or fever was noted. As of 6/7/01, symptoms had completely resolved.
Fever 101.4 and very swollen Left axillary lymph node (larger than an egg)
Fever, chills, body aches, body tingling, severe headache for 2 days, chest tightness and increase in anxiety that lasted on and off for about 8 months.
At around 8pm on the night of the injection, I became ill and my temperature started to climb. It got as high as 102.4 degrees fahrenheit and lasted 24 hours. As I showered after my fever broke, I noticed my left armpit was noticeably swollen in comparison to my right, like my lymph node there was enlarged. I was 5 days late for my period when I got the dosage, but since then I still haven't had it, now being 23 days late with no way of me being pregnant.
Right arm has pink raised area on inner portion-above antecubital space between elbow and axillary area-approximately 2 inches X 4 inches, no fever but area is warm to touch. Vaccine site slightly raised- no redness at site.
Soreness, redness and swelling at the shot site; Soreness, redness and swelling at the shot site; Soreness, redness and swelling at the shot site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 0029N3 and expiration date; not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 16:00 (Age at vaccination: 59 Years), as a SINGLE DOSE for covid-19 immunization. The patient's medical history included type 2 diabetes mellitus, hypertension, blood cholesterol increased and depression. The patient previously took jardiance and experienced hypersensitivity, simvastatin and experienced hypersensitivity, victoza and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021, the patient experienced soreness, redness and swelling at the shot site. Patient did not received treatment for adverse events. No covid tested post vaccination. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Muscular pain in left arm from site of injection to elbow,tingling in fingers unable to tolerate pressure on left arm.Joint pain
Heaviness in body for 3 weeks  followed by Moderate-severe joint pain on going.
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm. On 10/19, approximately 1 hour after this, the patient was given their first dose of COVID vaccine with this vaccine. No harm detected.
15APR92 parent phoned, stated pt had temp, t105 & had a seizure, stop breathing; To ER via ambulance states today has t103; MD checked for menningitis;
NOT SLEEPING DEEPLY; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (NOT SLEEPING DEEPLY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (NOT SLEEPING DEEPLY). At the time of the report, SLEEP DISORDER (NOT SLEEPING DEEPLY) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided  No relevant concomitant medications were reported
8-10mm erythema, mild swelling at injection site immediately following. Non progressive. No systemic or anaphylactic rxn.
Diagnosed with COVID-19 on 3/24/2021 with symptom onset of 3/20/2021 S/S:  Sore Throat, Aches, Fever, Fatigue
Initial unsolicited report received from the literature on 04-Jan-2018. The following is verbatim from the article: The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use. The group has 15 voting members, and each member's term is 4 years. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from multiple agencies are present as liaisons to the ACIP. The ACIP met on June 21 to 22, 2017, to discuss catch-up vaccination for hepatitis A vaccine, influenza surveillance, influenza vaccine effectiveness, herpes zoster vaccine, the effect of varicella vaccination on the incidence of herpes zoster, meningococcal disease in patients taking eculizumab, and considerations for a potential third dose of MMR vaccine to combat ongoing mumps outbreaks. Updates on dengue virus epidemiology, Zika virus vaccines, anthrax vaccine, yellow fever vaccine, and the Vaccine Adverse Event Reporting System were given also. This case involves a 16-year-old female patient who was vaccinated with doses of MENACWY VACCINE and MENB-4C VACCINES (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unspecified date. The patient had medical history of paroxysmal nocturnal hemoglobinuria. Concomitant medication includes eculizumab for paroxysmal nocturnal hemoglobinuria which started on an unknown date approximately one month earlier. On an unspecified date, six months following the vaccinations, the patient experienced fatal meningococcal disease and vaccination failure. Laboratory investigation and corrective treatment were not reported. On an unknown date, the patient died despite apparently strong memory antibody response to the strain. It was unknown if autopsy was performed or not. List of the documents held by sender: none. Sender's Comments: Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. Concomitant medication in this report of fatal meningococcal disease included eculizumab for paroxysmal nocturnal hemoglobinuria. Eculizumab is a terminal complement inhibitor and therefore increases patient risk for meningococcal infections. Patients treated with eculizumab and without a history of prior vaccination are recommended to receive a meningococcal vaccine at least 2 weeks prior to receiving the first dose of eculizumab and be revaccinated according to current medical guidelines for vaccine use. In this case, vaccination with MenACWY and MenB meningococcal vaccines occurred prior to initiating treatment with eculizumab. Importantly, this case does not represent a confirmed vaccine failure to MenACWY because information on the specific serogroup involved was not available. The isolate initially was reported to be serogroup B, but subsequent testing revealed that the strain actually was nongroupable. Reported Cause(s) of Death: Fatal meningococcal disease.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
Measles-like rash appeared all over my body - neck down only.  Not on face or head.  No new foods, medications, sun exposure, topical creams, new detergents etc. preceded the reaction. Oral anti-histamines had no effect. Rash continues to spread after 2 days. Urgent care administered methyPREDNISOlone Sod Succ Inj . Prescribed Triamcilone Acetonide for itchy neck and predniSONE Oral Tab for 3 days.   The rash is only itchy on the neck and I feel fine - no fever or other symptoms.
Severe dizziness, extreme headache about an hour later. Balance issues. By evening- strong chills, stomach ache, some mental confusion nausea. ( Moderna vaccine)
Post-menopausal woman began having severe PMS symptoms after coworkers received 2nd dose and after having had no menopause symptoms for over a year. Symptoms have persisted for over two weeks.
Accelerated heart rate beginning approximately 15 hours after injection.  Included tightness in chest, which began approximately 12 hours after injections.  Accelerated heart rate last approximately 7 hours, even while laying completely still.
Extreme headache, fever of 104, body aches, chills, nausea and vomiting
Patient is a 13 m male here for evaluation of rash & fever. Had 12mo vaccines 10 days ago, including MMR & VARIVAX: Rash started on chest, belly yesterday, today spread to back, face, top of thighs. No apparent pain or itching. Clingy, irritable, sleepy w/ more naps today. +PO, +UOP, no N/V. Runny stool today. Estimated lesion count: 50 on back 115 total. No vesicles, all dry or crusted papules.
1/11/2021 Nausea, 30 weeks pregnant- premature rupture of membranes
Expired dose of Ipol was inadvertently administered to a four month old patient/ No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a four months old male patient who was inadvertently administered a second dose of 0.5 mL of expired vaccine IPV (VERO) [IPOL] (lot P1A461M and expiry date 03-May-2020) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) on 04-May-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); HIB VACCINE CONJ (TET TOX) (ACTHIB); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  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
Gave booster shot to 15 year old. Approved only for 16 and up. No side effects currently
Rash in apper arm in C5 dermatomal distribution .  It goes toward elbow, not centered on site of shot
Patients reports numbness, pins and needles pain on her left arm where vaccine was administered. She reports no fever but say pain radiating to the back of her arm making it difficult to carry normal function. This was over a 10 day period.
- Became tireder than usual immediately after booster was administered. This occurred after the previous injections but less severe. Tiredness necessitated a nap of over 2 hours Monday, a full night?s sleep (Usually has difficulty sleeping after that length of nap, especially late in the day),  sleepiness throughout Tuesday with a 4 hour nap in the afternoon, another full night?s sleep Tuesday night, felt better Wednesday and did chores and errands then took a 4 hour nap, then went to sleep earlier than usual (about 10 pm).   - Developed moderately severe headache after approximately 1 hour. Took 3 Tylenol (usually takes 2). Headache continued in severity throughout the rest of Monday and Tuesday. Headache receded to normal by Wednesday.  - Nausea appeared Monday night after a nap, approximately 8 PM. Nausea was severe by Tuesday morning and remained so throughout Tuesday. Wednesday morning is was much less and faded throughout the day. No vomiting occurred but a small trash can was kept ready just in case.  This is being reported Wednesday at 10:30 by her Husband.
Experiencing headache; Super congestion; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that the patient was supposed to get his second dose of vaccine on Monday (12Jul2021) but he had been experiencing headache and super congestion since an unspecified day. On 15Jul2021, the patient did not have fever and his temperature was 98.7 in the morning. The consumer wanted to know if congestion was part of the side effects of the COVID vaccine. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 06-APR-2018, the patient was vaccinated with a properly stored, but expired dose of VAQTA (lot # N012324, expiry date 05-APR-2018) for prophylaxis. No adverse effects were reported. No product quality complaint was present.
This is a spontaneous report from a contactable Physician. A child  patient of unspecified age ethnicity and gender received TRUMENBA at single dose on an unspecified date for immunisation, and MENINGOCOCCAL VACCINE at an unspecified dose, both via an unspecified route of administration for immunisation. The patient medical history and concomitant medications were not reported. The patient had a headache like a hour and a half later after receiving TRUMENBA and MCV on an unspecified date with outcome of unknown.
just Liquid Conjugate was used; just Liquid Conjugate was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter chatted via Web and stopped responding after stating adverse event, no demographics for health care professional or patient were provided. No additional communication outside of stated adverse event. No additional details were available. Additional supportive information: The patient inadvertently administered the liquid conjugate component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
The area around the injection site was described as "hot and swollen" In addition, on the morning of 10/11/2021, the patient woke up with lymph nodes under her armpits swollen.
Admitted through the emergency room with cough, shortness of breath and hypoxia and found to have pneumonia secondary to COVID-19. Supportive care w/VitC, steroids, zinc, O2; weaned to RA for discharge
pt recvd vax; devel t of 103 w/in 3 hrs of vax; on 19aug94; MD notified & advised cool bath which brought t down; pt restless 4 x during day, pt cried; high pitch cry each time; seen at er; sxs resolved;
Body aches, chills, headache, fatigue, malaise, bedridden. Began 8 hour after vaccination, lasted 36 hours
blue finger tips--red spots on upper legs that turned black the next day--100 degree fever-nausea-headache--upper legs swelled up and  was discolored  for a few days
On August 27th (two days after second vaccine), had sudden onset of pain in upper left arm without any injury or trauma. The next morning I woke up with numbness and tingling down the side of my left arm and left pinky and ring finger. Has not resolved in almost a month, with intermittent pain through my left arm. Diminished sensation in pinky and ring finger, overall muscle weakness and poor coordination in left hand.
About an hour after the shots he started to break out on his stomach. I called the health department and they told me to give him Benadryl and if it got worse to call his pediatrician. By the next day it was under his arm pits and on his stomach. I called his pediatrician they told me it was normal and said continue the Benadryl. By Friday he was covered from head to toe in a a red whelped rash. I took him to facility to see him they told me it just has to run it?s course and continue the Benadryl and start Zyrtec. They also referred us to an allergy specialist at Allergy and Asthma but they won?t believe me when I say this is still an issue as of April 15th 2020. So I am not reporting it in hope this won?t happen to someone else and then just be swept under the rug. My sons face is still broken out and we have been on Zyrtec and a liquid steroid and nothing is helping.
Taking a flu shot knocks patient down for three weeks, haven't had the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer(patient) via social media on 29-Oct-2020.  This case is linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306276, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involves a patient of unknown demographics who taking a flu shot knocks patient down for three weeks, haven't had the flu (Influenza), while he/she received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect the patient taking a flu shot knocks patient down for three weeks, haven't had the flu (Influenza).  No laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for influenza.  There will be no information available on the batch number for this case.
24 HOURS AFTER TD VACCINATION SHE DEVELOPED A FEVER OF 105.1 AND IT STAYED AT 104.3 FOR 4 DAYS. VOMITING FOR 2 DAYS WEAK AND UNABLE TO WALK OR BARELY STAND. SLEPT CONSTANTLY. EVEN WITH MOTRIN AND TYLENOL FEVER ONLY REDUCED TO 103.8 . THIS LASTED 7 DAYS THEN FEVER DOWN TO 102.9 AND STILL THERE. SHE WILL NOT EAT AND CANNOT EVEN GET HER TO EAT CANDY. SHE IS STILL SLEEPING ALMOST 20 HOURS OUT OF THE DAY BUT SOME IMPROVEMENT IS NOTICED AFTER 10 DAYS. (VERY SMALL) MD SAID IT WILL TAKE TIME TO RECOVER. SHE IS VERY THIN EVEN BEFORE INCIDENT ONLY WEIGHED 45 LBS NOW SITUATION IS DANGEROUS BECAUSE SHE WILL NOT EAT.
On 04/29/2021 at approximately 5pm I had a blackout event lasting from 5pm until 1:30am the next day. During that time, several behaviors which could be categorized as "out of character" were exhibited. Ranging from verbal nonsense to what was categorized by Medical Center as "temporary psychosis" resulting in physical violence. The violence and lack of response to verbal commands was severe enough to warrant arrest by police after discharge from medical center. No memory of the events from 5pm to 1:30am exist.
I have a constant ringing in my ears.  Assumed it would go away or part of the body responding; however, it has not stopped.