chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS managed the patient's condition on-site.
Information has been received from a physician concerning a male child with allergies to sulfates who was vaccinated with a first dose of hepatitis B virus vaccine. The physician noted that he did not give the vaccination and that the child received it as his primary care physician's office. The reporter indicated that the patient had a lot of respiratory problems after vaccination as a reaction to what he believed to be the aluminum hydroxyphosphate sulfate in the vaccine. The physician was not sure what treatment the patient received for the respiratory problem, but he thought that the child may have gone to the ER, although he was not sure. Upon internal review, a lot of respiratory problems was considered to be an other important medical event (OMIC). Additional information has been requested.
extensive DVT left LE. diagnosed on 4/10/21, however symptoms started in week prior. Had almost immediate cramping/pains after vaccine that worsened after first week
Noted baseball sized area of redness that began on Saturday 4/6/19 (day after receipt of vaccine)  that continued to expand in size throughout Tuesday, 4/9/19 and reported area was now size of softball.  No drainage, warmth or tenderness noted.  Denied fever and reported ROM WNL.  As of Wednesday, 4/10/19 reported that area of redness  subsiding and "becoming lighter and difficult to see".
Patient received the PREVNAR 13 on 12/9/14 at approx. 8:45 AM. She reports that her left upper arm started to swell, with a red rash spreading to upper part of shoulder later that afternoon. No pain at site, no restriction in shoulder ROM, slight itching. No reaction to her last Pneumococcal vaccination. Was seen by another provider on 12/16/14, and treated with antibiotics for 5 days. Patient in the process of recovering. Caller her 12/17 at 3 PM and patient states that she seem to be improving at the injection site on left arm.
10 days post vax, Pt devel tenderness/erythema inject site. Dec 30, pt devel induration 1 1/2 inch diam w/3 small vesicular lesions. Pt exp pruritus and had broken vesicles.Lethargic,slight fever, flu-like symptoms/achiness.
Stopped menopause and now periods are super heavy and abnormal large clotting during periods.
Constant tinnitus that I first noticed within two weeks from second dose of the initial vaccine. It has not abated since it started. Does not affect hearing, but is omnipresent when other sounds do not drown it out.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 14:15 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID-19, brand=Pfizer, First dose, lot number=Unknown, lot unknown=False, administration time=02:45 AM, vaccine location=Left arm), administration date: 12Mar2021, for COVID-19 immunization, reaction(s): "Hives", "Itchy throat", "Swelling redness of skin", "Swelling redness of skin", "Stiff muscles", "Extremely fatigued". The following information was reported: PH BODY FLUID ABNORMAL (non-serious) with onset 04Apr2021 14:15, outcome "unknown", described as "Ph unbalance second dose third day". Additional information: Clinical course: The patient had Allergies. The Patient did not had Covid-19 prior vaccination and was not tested for Covid-19 post vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received other medications within 2 weeks of vaccination. Hospital is reported as Facility where the most recent COVID-19 vaccine was administered. Other medical history reported as Yes (not specified). Ethnicity and Race information are available. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt started to feel nauseated a couple hours after the shot was given. Then she felt very dizzy and her vision became blurred. At one point everything went black with her vision. She had to lie down because she felt like she was going to faint. Her head then started to pound- continued with a horrible headache.
Pt recvd 3 doses of Engerix-B & was found to have a neg titer; pt recvd 4th dose of Engerix-B 18SEP91 & how has a pos titer result;
Patient was put on Amoxicillin on 5/2 -- patient then broke out in a rash.  Amoxil was stopped and parent's started with Benadryl Patient then started on Friday/Saturday with blister like lesions/bubbles all over her body - clear drainage.  Patient with fever up to 100F today.
could have died; In the ER his blood pressure dropped to 80/60; anaphylaxis; face and lips swelled up; face and lips swelled up; blood pressure went through the roof/blood pressure dropped to 80/60 something; got stung by many yellow jackets; He was never allergic to bee stings before getting the shingrix vaccine.; rash presented on his back, legs, buttocks hips and under arms/ The rash was very itchy.; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced itchy rash. On 28th August 2020, the patient experienced anaphylaxis (serious criteria GSK medically significant), facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting. On an unknown date, the patient experienced near death experience (serious criteria GSK medically significant) and blood pressure decreased. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved and the outcome of the near death experience, blood pressure decreased, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting were unknown and the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the anaphylaxis, near death experience, blood pressure decreased, itchy rash, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had his first dose 3 weeks ago from reporting date in his left arm. Three to four days following the injection, a rash presented on his back, legs, buttocks hips and under arms. More on the right under arm than the left but still present in both areas. The rash was very itchy. The patient took benadryl on and off and even though it did not fully resolved, it was manageable. On 28th August 2020, the patient was working out in the yard and got stung by many yellow jackets and went into anaphylaxis. His face and lips swelled up and his blood pressure went through the roof. He was transported to the emergency room, treated and released. The patient was never allergic to bee stings before getting the shingrix vaccine. The reporter stated that the patient could have died and in the emergency room his blood pressure dropped to 80/60. The reporter consented to follow up. This case is linked with case US2020180921,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180921:same reporter US-GLAXOSMITHKLINE-US2020AMR181528:same reporter
pt recvd vax w/large red hives on back & legs, also starting to break out w/chicken pox (sister had them 2 wks ago); no fever or very mild; appetite & eating as usual; pt taken to clinic examined;
neck pain; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-DEC-2022. Reporter's Comment: This case was received from consumer via interactive digital media. The reporter want to know was a neck pain side effect of shingles shot The follow up would not possible as no contact details were available.
Client called stating that she had her booster COVID-19 vaccination in January 2022. Four months later, a "dent at the injection site" and a scab appeared at the injection site. Client states she had a physical, but this complaint was not addressed at the visit. The client has not sought medial care for this complaint. While taking her to the pediatrician, the pediatrician asked what happened to the clients arm. She stated it was from her COVID-19 vaccine. Dr. advised to have it assessed. Client called the Health Department. The client was asked to relay the events and her concerns. Client was advised to see a healthcare provider about this complaint as soon as possible. Client was given information about VAERS and that a report would be submitted by Health Staff.
Moderate varicella 7 days after vax, OM and a febrile seizure. Illness underway.
uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fever, extreme fatigue
patient aged 64 received Fluzone HD for 65 years and up.  NO adverse reaction was observed
Two days after my shot, I started experiencing a pounding heart, heart palpitations, sharp chest pains, chest tightness, occasional dizziness and shallow breathing, and fatigue. Additionally I have felt these poke-like pains in random parts of my body (arm, back, top of head, groin)
Left leg soreness, swelling to twice the normal size with hives around injection site, skin taut.
ARM IS VERY SORE AT INJECTION SITE AS WELL AS PAIN TRAILING TO UPPER SHOULDER AND NECK. PAIN IS VERY INTENSE AND CONSTANT AFTER ONE MONTH OF INJECTION. I DONT KNOW WHAT KIND OF DOCTOR I NEED TO SEE FOR THIS. I FEEL THAT THE PERSON THAT ADMINISTERED THIS HIT A NERVE IN MY ARM,AS IT WAS VERY PAINFUL AT TIME OF ADMINISTRATION.
wife states pain in upper lt arm of husband started 13AUG96 & has steadily inc & gone down arm;pt exp weakness of lt arm & the pain goes into hand;pt works as mechanic but not able to trim bushes d/t inc weakness-pain;referred to MD
dose of the Moderna vaccine was administered that was expired by two days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported.  No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow up : Event start date added., anatomical location of vaccine updated, patient demographics added
Pain and swelling, 4 days, post vax, and 4 days later, an open area developed. Was advised to put on Neosporin and dressing. To be seen again in 3 days.
Injection site is red, itchy, swollen.  Warm to touch.  The symptoms got better a few days after the vaccine, but yesterday the same symptoms came back and are getting worse,  It is now two weeks after the vaccine.
Felt I warm sensation through my whole body, got light headed and could feel my heart beating strong.
Upper respiratory infection; Immunodeficiency; Mobility decreased; Acute bronchitis; This is a solicited report based on the information received by Pfizer from a Pfizer sponsored program (Mfr. Control No.: 21K-163-3941315-00) received from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 06Jan2021 (Batch/Lot number was not reported) at the age of 60 years old, as DOSE 2, SINGLE for COVID-19 immunisation; and risankizumab (SKYRIZI), subcutaneous from Dec2019 (Batch/Lot number was not reported) and ongoing, at 150 mg (1 in 12 wk) for psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced acute bronchitis on 2021, upper respiratory infection on Apr2021, immunodeficiency on 2021, mobility decreased on 2021. The patient was hospitalized due to the events. Clinical course of events was reported as follows: In 2021, the patient experienced acute bronchitis, lowered ability to fight infections and cannot get out of bed. In Apr2021, the patient experienced upper respiratory infection. Additional information: In 2021, after the receipt of second Pfizer injection on 06Jan2021, the patient had first noticed that she was down for four days, felt like flu and could not get out of bed. She was hospitalized for acute bronchitis. In mid Apr2021, she had an upper respiratory infection and was hospitalized. She still had shortness of breath but was improving. She had felt Skyrizi had lowered her ability to fight infections. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer (intramuscular). On 06Jan2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for risankizumab was dose not changed. Outcome of the events was recovering.   Causality for risankizumab: The reporter's causality for the events of acute bronchitis, upper respiratory infection, immunodeficiency and mobility decreased with risankizumab (SKYRIZI) was a reasonable possibility.   The reporter's assessment of the causal relationship of the events (acute bronchitis, upper respiratory infection, immunodeficiency and mobility decreased) with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Pfizer comment: Based on the available information, there was not a reasonable possibility that the events acute bronchitis, upper respiratory infection, immunodeficiency, mobility decreased were related to suspect vaccine bnt162b2 due to the lack of a plausible mechanism implicating the vaccine to the events. The events were most likely related to suspect drug risankizumab based on the known safety profile of the product.
Tenderness on left collarbone and tenderness under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 05Feb2021 15:00 (at the age of 50-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included type 2 diabetes, allergy to penicillin, COVID and allergy. Concomitant medication included cetirizine hydrochloride taken for allergy, start and stop date were not reported. The patient experienced tenderness on left collarbone and tenderness under left arm pit on 06Feb2021 13:00. Tenderness was treated with topical steroids then oral steroids and it was resolved on an unspecified date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
HEADACHE; MUSCLE ACHE; CHILLS; FEVER; PULSE RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 17:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced pulse rate increased. Laboratory data included: Fever (NR: not provided) 99-102.7 F. Laboratory data (dates unspecified) included: Pulse increased (NR: not provided) 130 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache, chills, fever and pulse rate increased was not reported. This report was non-serious.
ALTS (see ER report ) Patient is a previously healthy 2mo old who presents to the ED after an apparent life-threatening event. Per MOC, patient received 5 immunizations today, had been well-appearing, eating well, active, etc. Patient then had episode of emesis; was NBNB, looked like formula. Immediately following this, patient began to look very pale, with cyanosis of lips. MOC became very concern and immediately called pediatrician's office. As she was calling the pediatrician, patient became progressively more pale/cyanotic. As a result, MOC hung up and dialed 911. While awaiting EMS, patient persisted in being cyanotic, then gradually improved. By the time EMS arrived, patient was more pink and well-appearing. Throughout this episode, patient was moving actively, did not appear to become apneic. Patient regained color without any active attempts at stimulation from MOC. Patient was transported to ED by EMS. Monitor in ambulance was not working, but patient appeared well throughout transport.  10/03/2007 VAERS report submitted with MR attached for hospital DOS 10/1-2/2007 for DX of ALTE. Child presented to local ER after an episode of emesis followed by pallor and cyanosis of the lips, and decreased responsiveness.  Transported by EMS to hospital with some improvement in color. PMH: none. NKDA Pt had another episode of emesis followed by a color change to ashen gray and cyanosis of the lips shortly after arriving in the ER.  PE significant for diffuse pallor.  Transfered to a hospital for further eval with same DX of ALTE.
The site of the injection has a small bump and is still itching 5 months later; The site of the injection has a small bump and is still itching 5 months later; This is a spontaneous report received from a contactable consumer. This 69-year-old female consumer reported.  A 69-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 20Mar2021 12:00 AM (at the age of 69-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history includes Blood cholesterol increased and Allergy to arthropod sting from an unspecified date and unknown ongoing and concomitant medications were not reported. On 30Mar2021, after the vaccination, the patient experienced the site of the injection has a small bump and is still itching 5 months later. No other vaccines were taking in four weeks, patient was not diagnosed with Covid before vaccination and patient was not tested for Covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
The day after my vaccination i had a bad cheat pain, i thought it was gas. The next day after noon i started to get rapid and hard heartbeats that were a little annoying. I thought those were only momentary, but they lasted all night. And since then, every day i have that same symptom that makes me t up at nights because of the loud heart beat
slight chills and muscular aches. no fever. lasted 2.5 days. took (1) 200mg Ibuprofen on 01/30, 01/31, and 02/01 Chills only on 02/1
part of the medication combo was not administered (with no reported adverse event); Initial information received on 21-Apr-2022 regarding an unsolicited valid non-serious case received from Other Health Professional.  This case involves a 2-month-old female patient for whom part of the medication combo was not administered (with no reported adverse event) while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV (MRC5)/HIB (PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine (Rotavirus vaccine), hepatitis B vaccine (Hepatitis B vaccine), and pneumococcal vaccine CONJ13v (CRM197) (Prevnar 13), all for prophylactic vaccination.  On 21-Apr-2022, the patient received the only DTAP/IPV portion of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine with unknown formulation, strength, (dose: 0.25 mL to 2 mL for vaccine) (lot UJ592AA, expiry date: 18-Dec-2022) via unknown route in the right thigh for Immunization.  On 21-Apr-2022, physician gave the Dtap/IPV portion only  of Pentacel to the patient and another part of the medication combo (ACT-HIB) was not administered (with no reported adverse event) (incorrect dose administered) (latency: same day).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.  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.
Chronic hives and dermatographia, starting 12/15/21, remains ongoing at present time