chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Transverse myelitis (numbness/tingling of feet that gradually progressed up to the level of the lower chest) - symptoms started about 3 days after the vaccine was given and the patient came to the hospital about a week after the vaccine was given
Hep A, MMR, Var on 10/2/18 fever started 10/5 103 seen in office 10/11 fever 100.3 (fever 6 days) rash on (R) thigh around VARIVAX injection site 3 small raised spots over a reddened area.
Right arm - arm that injection was given in  - has been cold, numb and tingling since the vaccine.  Fingers especially feel cold and there is pain in my wrist
pt reported generalized pruritus after receiving 2nd dose of pfizer vaccine, vital signs stable, pt given 50 mg Benadryl po, pt reported decreased sensation of pruritus after receiving Benadryl po
First one mild head ache. Second one extremely sore arm, full body aches, fatigue fever, sweats. Missed work.
I experienced left sided paresthesias for about 3 hours after receiving the dose and it started during my drive back home which was uncomfortable and scary.  Initially, I experienced numbness and tingling that radiated from the injection site up my neck and in to my face. This started about 10-15 minutes after receiving the vaccine.  It then radiated down my arm to my fingertips and eventually all the way down to my toes.  My foot went numb and some of the toes cramped up for about 30 minutes or so.
This spontaneous report as received from a certified medical assistant referring to a 14 year old patient of unknown gender. No medical history, concurrent conditions and concomitant medications were reported. On 15-JAN-2015 the patient was vaccinated with the 1st dose of GARDASIL (strength, dose and route not reported), lot # H020901 with an expiration date of 05-JUL-2015 (also reported as 08-JUL-2015) which experienced a temperature excursion (incorrect product storage). No adverse effects reported. This is one of the two reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Extreme fatigue Fevers of up to 103.5F Could not get warm Body/joint aches (even knuckles on both hands)
Patient experienced syncope about 10 seconds after vaccine administration. Before regaining consciousness he shook slightly and urinated. After about 10 seconds he regained consciousness threw up a minute or two later. After about 30 minutes he was feeling back to normal.
This case was reported by a physician and described the occurrence of wrong route of administration in a subject of unspecified age and gender who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccination included HIB vaccine (manufacturer unspecified) given in 2003.  In 2003 the subject received unspecified dose of PEDIARIX in an unknown thigh.  In 2003, at an unspecified time after vaccination with PEDIARIX, the subject experienced purple bruising.  It was reported that PEDIARIX may have possibly been administered subcutaneously.  This would be a wrong route of administration.  At the time of reporting the outcome of the events was unspecified.
Rash. raised, red, no vesicles located on abdomen, chest and back spreading onto neck and proximal arms
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
Patient received the 2nd dose of Shingrix on 5/26/2020 via IM . Patient call the pharmacy on 5/29/2020 complaining about  soreness, little swelling, and pinkish skin color at the site of the infection. The swelling size is about 3x3. Patient reports no warmth at the site of the infection.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed along with the additional information received on 12-JAN-2022 and 14-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total administered to the right arm on 29-JUN-2021 for prophylactic vaccination. No adverse events were reported by the patient following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, following vaccination with  covid-19 vaccine ad26.cov2.s, the patient experienced itchy throat. On 10-JAN-2022, the patient experienced cough and headaches. Laboratory data included: Antigen rapid test ) which was positive (coded as suspected covid-19 infection and suspected clinical vaccination failure). (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000211135. The suspected product quality complaint  has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220117083-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
6JUN97 lt leg became reddened, hot & tender to touch;knot felt in same area;t99.8;pt called MD & was told that there was abscess & pt placed on med x 7 days;
This case involves a 14 months old male patient who had HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) powder which not mixed with sodium chloride diluent; mixed with sterile diluent for live virus vaccine (product preparation error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (lot and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination. On 13-Dec-2021, the patient received a dose of suspect ACT-HIB (Solution, 0.5 ml, total, once, lot UJ581AA and expiration date: 14-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to wrong diluent used (same day latency). It was reported "Nurse reports that they had an ACTHIB administration error, states that ACTHIB powder was not mixed with the sodium chloride diluent that comes in the box, states ACTHIB powder was mixed with sterile diluent for live virus vaccine. Nurse asks if there are any recommendations in this situation and if there could be any harm to the patient. Nurse states that the patient did not require any treatment after receiving ACTHIB; states the parents have not yet been notified, but to their knowledge the patient has not required any treatment" No reported adverse 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 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.
Itching, burning and sore at location of actual injection. Arm is "hot" to the touch and muscle feels tight. Skin feels like there is a rash.  Appearance of red rash is circular and has spread in 24 hours. Arm is also more sore on Day 2 of adverse reaction.
Fever (103.4 degrees F by 3:00 am) & 102 degrees F. Pt took ASA 325 mg, then fever subsided and delirious, holding on to bed, couldn't follow directions. Temp 97 degrees in am next morning
had a response in her nervous system.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 02Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "had a response in her nervous system.".Original INT: Call transferred by (name) from agency, NTID: #, Reportum: #. Caller had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Sep2021 and had a response in her nervous system. She has very little primary healthcare but have alternative medicine HCP instead. She barely take antibiotics or any medications. She is asking if there are different variety of dosage for the vaccine for people over 65 years old as she is concerned on the dosage she received.  Follow-up (05Nov2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent to consumer via telephonic follow-up activity which included that: Phone-Out 12:45 PM, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who did not provide her e-mail address instead provided her mailing address.  Follow-up (13Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low back pain left side and spreading to right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Low back pain left side and spreading to right side) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D32L26A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced BACK PAIN (Low back pain left side and spreading to right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Low back pain left side and spreading to right side) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received included no new significant information
receive 0.3ml of undiluted Pfizer COVID 19 vaccine; 0.3 ml of undiluted vaccine administered; swelling in his arm; This is a spontaneous report from a sponsored program via a contactable pharmacist. A 14-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller who states that they have a patient who is a 14 year old male who receive 0.3ml of undiluted Pfizer COVID 19 vaccine. He is having swelling in his arm and is now in the ER. She states that AE has already been reported via VAERS. She would like to know if there is any information on this occurring with others? Dosage Higher-than-authorized dose volume administered. Diluent (Pfizer-BioNTech COVID-19 Vaccine only). No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered). The second dose of vaccine should still be given as per the recommended. Event outcome was unknown. The trial showed that although a stronger dose (100 micrograms) was not harmful, the recipients experienced more local reactions with very painful arms being reported. Participants who received 58 micrograms of COVID-19 mRNA Vaccine [the product currently marketed in the U.S. as Pfizer-BioNTech COVID-19 Vaccine] in clinical trials did not report an increase in reactogenicity or adverse events. If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. They should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm.   Information on the lot/batch number has been requested.
10 days after second shot got a week long fever of 102, that only went down 7 days later. Muscle aches and fatigue and fever. However after the fever went down on May 7 or 8, constant muscle pain in both legs, both arms, and both hands. Hands are now arthritic with nerve pain, which is new. Hips very painful and stiff.
Rash that progressively got worse and spread to face, trunk, arms and slightly on both legs. Rash took nearly 3 weeks to go away. Low grade fevers. Wheezing started on 8/31 requiring albuterol breathing treatments.
Red area approximately the size of a half dollar on right arm at site of DTaP, warm to touch. Mom states the swelling is going down.
The next day I felt super achy and feverish. Lasted about 2 days and then symptoms went away.
1- 24 hours after vaccine: baseball size, red, hot raised area at injection site, flu-like symptoms of extreme fatigue, muscle pain, headache, nausea that lasted @ 36 hours, red, raised area at injection site resolved by 2/26/2021...5 days later. 2- 7 days after injection - injection site began to itch slightly, itching progressed over the course of the week (2/28/2021) and baseball sized red area appeared again at injection site, red area at injection site resolved @ 7 days later, itching has declined but still flares up occasionally.
Patient with 2 COVID vaccinations (although not following regular schedule), with last dose on 01/18/22 who admitted to hospital with wound infection.  No respiratory issues during stay.  Provider discharge note below:  "62 YO male w/ history of Lung cancer on Keytruda presented with right leg and abdominal redness. Non febrile on arrival and labs without leukocytosis. Patient admitted for right leg cellulitis.    During his stay, he was given IV Zosyn, Vancomycin in the ER. IV Zosyn was stopped and IV Ancef was started. MRSA nares test was negative. Patient was adamant to go home after staying overnight. He notes that he has had very bad experience from prior prolonged hospitalization (1-2 months) and will not want to stay any longer today. I have encouraged him to stay for close monitoring but he is eager and adamant to be discharged home. Blood cx are negative. He has been afebrile with stable vital signs. R leg erythema has markedly improved from the marked area since ER arrival. Abdomen redness has improved as well after placing Nystatin powder so this is likely intertrigo. Patient will be discharged home with 7 day prescription for Keflex with close follow up with his PRIMARY CARE PHYSICIAN. Strict return precautions given. "
12 hours later I had a fever, aches and pains, headache, and I was in bed for a few days. I also had stomach pain and thought it was weird because vaccine goes to weak areas and I've had gastritis before. I lost my appetite as well. Symptoms lasted for 3 days.
Patient developed a red splotchy rash on right upper arm. He is currently taking Benadryl and it seems to be getting better. Patient has been instructed to seek further medical attention if condition worsens.
Patient came in to receive 4 vaccines and instead of getting the Fluad 65+ shot received the Shingrix instead. Patient was immediately contacted and no side effects had occured. Patient will be coming in next week for the flu shot.
Information has been received from a physician concerning an approximately 12 year old female who on approximately 6-MAR-2009, "about a week ago" from the reporting date, was vaccinated with the first dose of GARDASIL, 0.5 ml. No lot number was provided. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The physician reported that the patient fainted after receiving her first dose of GARDASIL. It was stated that "about a week ago" from the reporting date, on approximately 6-MAR-2009, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Premature rupture of membranes at 34 weeks pregnant. EDD May 29, 2021. Birth weight 5 lb 10 ounces.
This case was reported by a physician via call center representative and described the occurrence of maculopapular rash in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On 12th September 2018, the patient received the 2nd dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season at an unknown dose. In September 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced maculopapular rash, vesicular rash and fever. On an unknown date, the outcome of the maculopapular rash, vesicular rash and fever were unknown. It was unknown if the reporter considered the maculopapular rash, vesicular rash and fever to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient also received an influenza vaccine at the same time (unknown brand) along with SHINGRIX at pharmacy. The health care professional stated that, the patient presented on the reporting date, with fever and a disseminated maculopapular vesicular rash. In the health care professional's opinion, it was not Shingles since the rash was disseminated to his chest, back, trunk with no mucosal involvement. This occurred after patient's 2nd dose of SHINGRIX (when co-administered with influenza vaccine). The patient did not have these symptoms after their 1st dose of SHINGRIX.
incorrectly vaccinated a patient with Pentacel instead of Quadracel, No AE reported; The patient had received Pentacel at age 2 months, 4 months, 6 months, missed age 15, No AE reported; 5.5 year patient was vaccinated with Pentacel on left thigh, No AE reported; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6216AA and Exp. Date 30-Sep-2020) via intramuscular route in the left thigh, on 31-Jul-2019 instead of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past vaccination(s) included Pentacel at 2 months, 4 months and 6 months. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to wrong vaccine administered, missed dose and vaccine administered at inappropriate site.  It was reported that that she incorrectly vaccinated a patient with Pentacel instead of Quadracel. The patient had received Pentacel at age 2 months, 4 months, 6 months, missed age 15 months and then received a dose at age 5.5 years.   No AE reported.  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.
Second Pfizer vaccine caused achiness and soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4454382-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular), administration date: 25Feb2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Second Pfizer vaccine caused achiness and soreness".  Additional information: In Mar2021, the patient experienced second Pfizer vaccine caused achiness and soreness. In Mar2021, the second Pfizer vaccine caused achiness and soreness resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large painful local reaction with > 10 cm swollen, erythematous, indurated area with fever 102 degrees F.
Somewhat flu like symptoms, mild fatigue, general nausea, basically feel like I just got over the flu or something, two days after it felt more like a cold, some sneezing and a runny nose for one day.... then turned into what felt like my normal response to pollen based allergies for like a day and now is more like day after as if i had the flu (or day before)  thought I felt better yesterday, worked - now I feel bad again.
Kidney Stone: severe right flank pain which caused an inability to stand/walk, vomiting, shaking, elevated blood pressure, etc. Labwork and scans showed kidney stone. Symptoms of pain began at 9:00am that morning, by 11:00am, I was in the ER receiving treatment, by 4 or 5:00pm, I was home with effective medication management for the pain and nausea, as well as to help pass the stone. Three days later, I passed two kidney stones. Most symptoms resolved within another two days. Seven days after the ER visit, I saw a urologist for a follow up which confirmed most likely all the stone(s) had passed and lingering symptoms would resolve. A follow up ultrasound to look for lingering swelling or scarring was scheduled. Today, eight days after initial symptoms, only fatigue and soreness remain.
PATIENT HAS RECEIVED BOTH COVID-19 PFIZER VACCINE, AND TESTED POSITIVE TO COVID-19 ON 8/18/21