chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in left elbow; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 81-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included diabetes and Guillain-Barre syndrome (GBS), under control. The patient's concomitant medications were not reported. The Caller was an 81-year male consumer, asking "was his symptom a reaction to the vaccine" and "did his shot take effect and do he get the second shot" Caller reports that he has swelling in left elbow on an unspecified date, and it looks like a golf ball and asks if this was a side effect of the vaccine. He reports that he received his first dose of the Pfizer covid 19 vaccine on Sunday morning about 10:00 am. The caller got the shot in the left arm. On mid-day Monday (on an unspecified date), he started noticing "left elbow had very slight swelling, / slight swelling in his left elbow he didn't think anything about it" but "this morning, right now, there was a swelling on his left elbow the size of a golf ball, a big round knot, really soft like it was full of fluid, but no pain". The caller states he thinks it was because of the shot because he has been very careful to not do anything after receiving the vaccine. The caller wants to know that knot on his elbow an adverse event to the covid shot, have we seen this before. Caller reports a history of diabetes and Guillain-Barre syndrome (GBS), under control. He also reports having spoken to his doctor who said it was nothing. He now asks what Pfizer thinks. He was very disappointed that Pfizer can't provide him direction on what he should do. Serious: No. The outcome of the event was unknown.   No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Became very exhausted tired all the time and just sleep a lot. She stated that becomes so said to she have the shakes
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), on 13Jan2021 as dose 2, single (Lot number: EL0142) and on 23Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Aortic valve insufficiency" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Borderline/ Mild hypertension well controlled" (unspecified if ongoing), notes: Borderline/ Mild hypertension well controlled; "GERD" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "arthritis neck" (unspecified if ongoing). Concomitant medication(s) included: Coreg; Nexium [Esomeprazole Sodium]; Mucinex; Flonase [Mometasone Furoate]; Zyrtec [Cetirizine Hydrochloride]; Vitamin C [Ascorbic Acid]; Vit D3; Menaquinone; Omega 3 Fish Oils; Turmeric [Curcuma Longa]; L-Theanine; Methyl B12; Methylfolate; D-Mannose Cranberry Extra. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: my rebound symptoms started and it was positive; (Aug2022) Positive; (15Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 7 days after finishing Paxlovid, patient experienced Paxlovid rebound symptoms such as sneezing, nasal congestion, slight dry cough. Patient also did a home Covid test 12 days after  first tested positive which was when patient's rebound symptoms started and it was positive. Patient had no known drug allergies, only diagnosed with seasonal allergies. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Systems started at Midnight and continued through early morning, 8:00 pm.  I finally got to sleep.  When I woke up, i just had mild systems-muscle ache and slight headache.  Pain at the injection site Headache Chills Low grade fever (100.2) Muscle pain (all over my body-from head to toe) Skin hurt at touch Skin felt like a rash, but no redness Could not sleep, because I was so uncomfortable
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness). In 2021, PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient after receiving the second dose experienced a sore arm and a little weakness that went away quickly. No treatment information was provided. This case was linked to MOD-2022-448394, MOD-2022-448414 (Patient Link).
half hour after receiving shot tongue and throat swelled up and  short of breathe.  Throat was sore for few days and short of breathe remained for almost a week  It is 12 days and feel better but do not know if I should get second shot
Brain fog, difficulty concentration,  heart palpitations, blurred vision, slow reactions, since 2 hours following first vaccine
DEAD; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I tried to warned as many people that would listen to me, not to take those dangerous shots very few people would listen to me, and some are dead now for not doing so. One lady (Not in my Sunday School Class, but is a church member), had two miscarriages after taking them. Everyone (53 members) in my Sunday School class took the shots, even though I warned them good not to take the shots Almost everyone in my class has had COVID since taking the shots They are now mighty quite about it all, when they announce that a member of our class now has COVID Some have had COVID the second time around, and they are filled up with those dangerous chemicals and man made viruses, that they allowed stupid doctors to give to them. When I was warning them, some of them said stupid things to me for not being protected, and risking other people's lives by catching it, and spreading it I don't hear a peep out of any of them now I did my research and I listened to "Real Doctors" Less". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221257582.; Sender's Comments: V0: 20221257674 -dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Bilateral hand and feet warts (peringual warts); HPV vaccine for bilateral hand and feet warts (peringual warts); This literature marketed report has been received from the authors of the published article, concerning a 52 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, cimetidine and imiquimod. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) bilateral hand and feet warts (peringual warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the bilateral hands and feet warts resolved (drug effective for unapproved indication).   The outcome of drug effective for unapproved indication was unknown.  The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Patient is postmenopausal  x 2 years and started bleeding heavily. Scheduled appointment with gynecology for evaluation
h/a, mouth ulcer, diarrhea 2 days p/2nd vax; devel the flu 10 days later;
2 days after administration I experienced severe muscle spasms from mid-thoracic region radiating down through lower limbs. This severity lasted 72 hours then lessening intensity daily. I have experienced this before years ago so perhaps coincidence?
Localized shot rxn. 4.5 x 4.5cm (L) thigh ant/lateral. 3.5 x 1.5 cm (R) thigh ant/lateral. (+) blanching, warm, NT.
4 days after injection, redness and severe itching at site. Treating with warm compress and Benadryl cream.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe
Tendonitis in her wrist; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received second dose of meningococcal group b rlp2086 (meningococcal serogroup B conjugate vaccine) (TRUMENBA Suspension for injection; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for immunization. The patient's medical history included being diagnosed with Lyme disease and Bell's palsy previously. The patient previously took first dose of meningococcal group b rlp2086 (meningococcal serogroup B conjugate vaccine) (TRUMENBA) for immunization. The patient's concomitant medications were not reported. The patient's mother was calling on behalf of the patient who is due on 02Apr2020 for the third dose. The patient was needed to be on 3-dose schedule as per healthcare professional. If the patient was late for her third dose related to COVID precautions, they were wanting recommendations on how long she can wait to get the third dose and still be effective. The patient's mother was also asking for recommendations on safe location (away from COVID risk) to get third dose in her area. The patient thought that the second dose was on 26Dec2019 but was not sure. The patient's mother confirmed that the patient was on time for the first two doses. On an unspecified date, the patient developed tendonitis in her wrist and had to have steroid injection in her wrist. The patient was advised to have the third dose at least 30 days after the steroid injections. The patient's mother stated that the tendonitis had nothing to do with the vaccine. The outcome of the event was unknown. The reporting consumer considered the event as unrelated to the suspect product.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Patient received imms on 8/18/08 and on 8/20/08 her Lt. thigh was red and swollen(5" by 4") per mom.She was seen by her own MD and also 4 times in the ER. Also seen by a pediatrician. Diagnosed with cellulitis and put on Bactrim. It did improve. She was given a second course of Bactrim but developed an allergic reaction to it and was switched to Zithromax.She has had fevers off and on as hihg as 102.5.
redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3249), NDC number, expiry date; unknown, Is COVID vaccine a Pfizer product; Yes, COVID vaccine manufacturer; unspecified via an unspecified route of administration from 01Feb2021 to 01Feb2021 at single dose on right arm (by injection once to right hand shoulder) for prevent from getting COVID. Identification of the country where the drug was obtained. Country of authorization/application;. Patient (weight; 60.78 kgs, height; 163 cm) was 76 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported (Other Products; No, Patient History; No). Caller received the vaccine on 01Feb2021 and experienced right away the redness and swelling at the injection site however this morning she woke up and it was itchy, as well as the redness and swelling. Caller had Pfizer shot two weeks ago, the COVID vaccine, everything was fine, but this morning, on 09Feb2021 her arm is itching, red, and swollen at the shot area, is that normal? Reporter email address declined. She stated it was itching really bad, she got her bath, and it looked red and swollen and was sore. Primary care doctor's address, phone number, and email address unknown. Vaccine card has the return shot date of 15Feb2021, the card doesn't have the date of the first shot. The outcome of events was not recovered.
Approx 30 min after vaccine slight tingling in right facial cheek/sinus area.  Sensation Felt similar to when novicane wears off after dental procedure
Pt complained of feeling dizzy after 12 minutes of post observation.  Pt lost consciousness for brief period.  Blood pressure dropped from 120/73 to 98/59.  Pt regained consciousness and was able to give one word answers.  EMS was called.  IV was started and IV fluids were administered.  Upon EMS arrival, pts blood pressure was noted to by 70/50 and she again lost consciousness.  Pt was transported to local ER by EMS.  Pt was later diagnosed with a vasovagal response to vaccination.
I do have osteoarthritis in shoulder, not bad. My left  shoulder ached of course, but by evening, sharp pain if i lifted it or moved my shoulder.  I massaged as advised, ibuprofen, ice, rest.  I had a week of chills, tired, aching,  low temp 99*,  but my arm got worse. My Dr advised continue doing above, ice/heat. I feel i have lost strength in my shoulder and though it has eased, the pain increases when i use my shoulder.
CDC Reports: 2 mo infant received DTP/OPV on 8NOV89 and 21NOV89.
PATIENT STATED FELT WARM AFTER VACCINE ADMINISTERED. HAS HISTORY OF FEELING FAINT WITH NEEDLES. PLACED HEAD DOWN BETWEEN KNEES, COLD CLOTH PLACED ON FOREHEAD AND NECK, VOMITED X3. MONITORED UNTIL RESOLVED, PATIENT STATED FELT BETTER AFTER 10 MINUTES. ASKED TO REMAIN IN WAITING ARE FOR 15 MINUTES TO MONITOR, PT COMPLIED. NO ADDITIONAL ISSUES.
15 min /p recving vaxs, pt had vomiting & diarrhea.Approx 3-4 hrs /p vax had neck stiffness,unable to move head.
Cognitive function Forgetfulness Dizziness Happens daily since I received the booster shot
Information has been received from a physician assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL vaccine (yeast), 0.5ml, intramuscularly for HPV prevention. The physician assistant reported that the patient fainted after receiving the vaccine. The patient recovered on the same day of the vaccination. The patient sought unspecified medical attention. Additional information has been requested. \
I have been experiencing extreme nausea for over a year since my first dose of the Moderna Vaccine. However it was aggravated more after every dose. I have seen three different Doctors for this issue. At present, they have not found the source of my nausea after multiple testing .
Pt reports to ER by ambulance about 19 hours post Hepatitis A vaccination with c/o hives and heart palpitations, chest pain and tingling. Pt given Benadryl 25 mg IM, prednisone 60 mg PO, Pepcid 20 mg PO. Pt discharged in stable condition with rx for Benadryl 25 mg PO, prednisone 20 mg PO, and Pepcid 20 mg PO.
"Covid Arm" occurred near the injection site in the left arm. Presented as a round raised site about 2 inches in diameter, hot and firm to the touch. This occurred 9 days after vaccination and was gone by 11 days after the injection.
Cement like feeling in limbs, fever, exhaustion, sleep so deep family worried about consciousness, vertigo leading to falling, confusion
received Shingrix . Developed shingles/Suspected Vaccination Failure; mild case of shingles.; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingrix. In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix in December 2018 and 2nd dose in March 2019. The patient recently developed a mild case of shingles.  The patient inquired if it was possible to receive a third dose of Shingrix.  The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
diagnosed with vestibular neuritis; collapsed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) and SYNCOPE (collapsed) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) (seriousness criteria hospitalization and medically significant) and SYNCOPE (collapsed) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Jul-2022 due to SYNCOPE and VESTIBULAR NEURONITIS. At the time of the report, VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) had not resolved and SYNCOPE (collapsed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient was not on concomitant medications. The patient did not have a history of dizziness. On 01-Jul-2022 patient was at work and got super dizzy and collapsed. The patient was taken to Emergency room and several tests were done and they admitted her. Reporter stated the patient was due for her second dose on 05-Jul-2022 but could not receive that since she was currently hospitalized. The patient was hospitalized at the time of the call on 07-Jul-2022. The reporter stated patient would be discharged on an unknown date to go for physical therapy at an inpatient rehabilitation facility since she was still dizzy and cannot hardly walk. Reporter stated that the doctors had not mentioned that was vaccine related at all. The patient was being treated with antibiotics, steroids, and other medications.  Company comment: This spontaneous case concerns a female patient aged 48 years, with no medical history reported who experienced the unexpected seriousness criteria hospitalization and medically significant events of vestibular neuronitis and syncope 25 days after 1st dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 48 years, with no medical history reported who experienced the unexpected seriousness criteria hospitalization and medically significant events of vestibular neuronitis and syncope 25 days after 1st dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Information has been received from a lawyer concerning a literature article where a 36 year old patient was vaccinated with a booster dose of RECOMBIVAX HB manufacturer unknown. Subsequently, the patient developed a progressive and ultimately fatal, inflammatory myelopathy polyradiculopathy nine days after the booster dose. It was reported that the patient had no fever or systemic illness and did not respond to extensive immunotherapy. No further information was available at the time of this report. Additional information has been requested. A copy of the published article will be provided, when available, as further documentation of the patients experience.
Patient received his 1st dose of the Pfizer COVID19 vaccine and within a few minutes reported feeling faint. Pt was diaphoretic and lost color is his face. Pt was moved to a cot to lay down and elevate his feet. BP: 89/45 repeat 76/50, repeat 100/71. HR 110, repeat 59. RR 16.O2sat unable to read properly, reading 60%-80%.  EMS called immediately, pt was evaluated by EMS and began to feel better. Pt?s mother signed refusal for transport to the hospital. Pt?s mother was given ED precautions and advised to notify the pt?s pediatrician. Pt?s mother verbalized understanding and agreed to the POC.
PT states that the Pharmacist hurt her while providing the vaccination.  Patient hasn't mentioned any specific details and isn't available to get in contact with to see what Pharmacy can do next/check her status.
Left axillary lymph node edema and tenderness, requiring anti-inflammatory medications to assist with discomfort and edema.
urticaria day after vaccines only other med was TYLENOL. no resp no GI s/s.