chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 71 year old male with multiple drug hypersensitivities Benadryl, Claritin, Aclovate, hypercholesterolemia and a history of constipation, dermotologic rash in right ankle, and heart stent placement (1996), on on 05-FEB-2007 was vaccinated in the left arm, IM, with a dose of Pneumovax (lot #651437/0899F). On 06-FEB-2007 the consumer experienced itching and developed redness in his vaccinated arm. He also stated that by 09-FEB-2007 he developed a rash all over his body except for his face (specifically mentioned his chest, stomach, back, buttock and legs). The consumer reported that on 10-FEB-2007, he experience difficulty in breathing, but did not visit the emergency room. The consumer reported that he took 10 mg Valium for his shortness of breath. On an unspecified date, the patient was seen by an allergy specialist who also prescribed prednisone, 10mg twice daily, to be taken from 15-FEB-2007 to 19-FEB-2007 for his rash. His breathing returned to normal (date not reported), but as of 19-FEB-2007, his rash remained. In addition, the consumer reported his "kidneys shut down for a period" (date not specified) but confirmed he had not been hospitalized, he stated he "has not been able to work since the vaccination" (05-FEB-2007). The consumer reported he "attempted to contact his physician but the physician would not seen him," and added that "the prescribing physician will not return his calls". He further noted that " if he had known that the side effects of the vaccine were skin rash and urticaria, he would not have accepted the vaccine because of his extensive allergy history." The consumer also mentioned that when he took Lipitor for four days he experienced constipation for 45 days. The event impaired work ability was considered disabling ("has not been able to work since the vaccination"). A concern regarding the lot was expressed. A lot check has been initiated.
This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (noticed ringing in her ears), FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 038B21A and 021C21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs). Concomitant products included COLECALCIFEROL (VITAMIN D3) and CALCIUM for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed). In April 2021, the patient experienced TINNITUS (noticed ringing in her ears). On 10-Mar-2021, FEELING ABNORMAL (immediately after she got the first shot, she felt kind of not herself/ she have shrunk) and DIZZINESS (little light headed) had resolved. At the time of the report, TINNITUS (noticed ringing in her ears) was resolving. No treatment information was provided. Height: 5'2.5" (patient says that she used to be 5'4" but has shrunk). Patient noticed after a month or so of receiving the shot that she was experiencing ringing in her ears. She said that the ringing was periodic, but annoying because she noticed it and knows that it was happening. She said that there had been a slight improvement in her symptoms since it first started and that the ringing had become a little less as days go by. She will be seeing an ENT this month to find out why she was experiencing the ringing in her ears. She also stated that immediately after she received the first shot she felt not herself and a little lightheaded. She felt like she needed to sit down and was glad she was told to stay for 20 minutes after the shot. This feeling lasted for an hour after which she started feeling normal again. She said that she has never had this experience with any other vaccines.
Nausea, vomiting, fever, chills, fatigue, body ache, stomache upset
Redness, size of half dollar, at injection site. No other adverse symptoms after 15/20 minutes.
Swollen site on my right arm  at the injection site, red round circle and itching also note upon touch there is no pain but the area is hard to the touch.
Patient started feeling left-sided numbness of face/arm and lower extremity. Patient felt weak. Was admitted to the hospital the following day for stroke-like symptoms.
The patient received the Boostrix vaccine in his L arm on 9/11/19.  On 10/25 the patient came in and showed me his arm which had a quarter sized red, swollen mark on it.  He was asking when he received the vaccines here and I gave him the date and told him the Tdap was administered in his left arm.  I advised him to have his arm looked at by a physician.  He came back on 10/29 and advised he did have his arm looked at today and the abscess was drained and cultured.  The doctor gave him antibiotics for the abscess.
pt recv vax 26MAR97 & had dizziness, felt faint & weak;malaise & aches in arms & legs;now 24hr later still feels ill but better;missed a day of work;
Patient is a 22 year old male with no significant past medical history who presented with 6 days of abdominal pain, nausea, diarrhea, headache, and muscle aches; symptoms were preceded by fever at home several days prior. He was admitted for pain control and intravenous hydration. Upon further questioning, it was revealed that the patient had received immunization for Japanese encephalitis, flu, and anthrax two days prior to symptoms starting. It was suspected that his symptoms were due to recent immunizations, possibly Japanese encephalitis vaccination. While admitted he received comprehensive infectious workup including urine culture, blood culture, COVID testing, respiratory virus panel that were negative. Chest x-ray showed no significant airspace disease but possible small bilateral pleural effusions with recommendation for follow up chest radiograph in 6 weeks to 3 months. Liver enzymes were noted to be elevated on admission, they downtrended, but remained mildly elevated after resolution of abdominal pain. Hepatitis panel negative. Labs also notable for slight anemia possibly due to administration of IV fluids and 3+ blood, 2 RBCs in the urinalysis with no signs of UTI, recommended repeat labs with PCM after discharge. He did not fever during his hospitalization and his presenting symptoms were resolved prior to discharge.   Due to possible vaccine reaction, the The Agency was contacted prior to patient discharge. The nurse practitioner from the agency stated he would contact one of their specialists for further recommendations or workup that should be done as an out-patient. He additionally recommended an allergy/immunology consult as an out-patient.
a patient experienced "Primary Ovarian Failure after being vaccinated with GARDASIL".; This spontaneous report was received from a physician, via company representative, referring to a 17-year-old female patient.     The patient's concurrent conditions, medical history, previously drug reactions, drug allergies and concomitant medications were unknown by the reporter.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) as prophylaxis.   The physician had written an article regarding primary ovarian failure (POF) and was later contacted by patient's mother, who stated that her daugther experienced primary ovarian failure after being vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). At the reporting time, the outcome of the event POF, as well as, if patient sought medical attention, or received treatment, or if laboratory diagnostics or studies were performed, were unknown.   Relatedness between the event POF and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
about 24hr p/vax red area about the size of folt ball @ inj site;site also sore & itching;MD advised APAP & DPH & ice packs;
Adult patient was administered a pediatric dose; Adult patient was administered a pediatric dose; This case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report.. The consumer reported that  patient was administered a pediatric dose of Engerix-B which led to adult use of a child product and under dose. The reporter consented to follow up.
Notes from visit: The patient presents with rash. She is not having fever. ther comments include: last week received PROQUAD in left leg, reddness started same night around site of injection, reddness increasing in size, every day since then mildly itchy non tender, + warm to touch, as per mom otherwise well. Follow up instructions: ont close monitoring/ cool compresses, may cont to inc in size over the next few days, then should start to resolve, if worsening symptoms, fever, pain or other concerns, return visit.
This spontaneous report as received from a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (strength, dose and frequency were not provided) rather than ZOSTAVAX. No adverse event reported. Additional information has been requested.
Myalgia, NauseaVomiting, sweating, fatigue Narrative:  Other Relevant History:
severe stiff neck & pain by 11NOV96 inability to move head to either side or to elevate chin, spot posterior to lt ear & @ base of head;sore as a boil & pain extending to inside lt ear, low grade fever;also pain lt arm-no inj site pai
Fever 100.7; headache. Started around 12 noon on 2/24 and lasted until 10 am 2/25.
pt brought to ER w/apparent SIDS;found in crib by caregiver;
Covid arm; the area was hot to touch; Itchy; Redness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient height was 5.6 or 5.7 F.  No concomitant medications was reported. Patient was taking medications. The patient never had Covid positive test or diagnosis. The patient did not experienced history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment details was reported.   This case was linked to MOD-2022-594051 (Patient Link).
Generalized hives. Redness warmth and swelling at injection site. Required IM dose DECADRON and oral BENADRYL.
This spontaneous report was received from a physician referring to unknown age and gender patient. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ intramuscularly (lot number, expiration date and dosage were not reported); the primary reported that it was outside the recommendations per the ROTATEQ prescribing information (Incorrect route of drug administration). No adverse effects were reported. The physician did not wish to answer any adverse event question. No product quality complaint was involved. Additional information has been requested.
Pt c/o open sore on left arm at injection site. Pt stated it was itching this am. Pt adds he started feeling bad friday the 15th in the evening and was in bed all weekend. Pt reaction was 4 x 5 mm open sore, 10 x 10 cm in redness. CTL
A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2010, the patient received FLUMIST. On 25-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
pt recvd vax 26MAR93 & on 28MAR93 devel a rash on the palms of hands & mother of pt was instructed to call the MD office if rash did not go away;
The pt experienced crying for greater than 1 hour with DTaP doses 1 and 2. The pt also experienced fussing, crying spells, difficult to calm down, crying out in sleep, redness with golf ball size swelling at injection site, small bumps in redness area and a large lump under injection site.
pt noticed a couple days after getting the vax he developed itchy hives on arms and legs that come and go.  States he takes Benadryl before he goes to bed.  He also had swelling in his lips that come and goes.  Pt has not contacted his PCP at this time.
From telephone note on 3/24: Recieved call reporting veteran had suddenly developed nausea, vomiting, and a fever to 102.8 yesterday afternoon. Wife concerned this could be related to the H1N1 Flu vaccine veteran recieved on Tuesday. Says she gave veteran Tylenol and sponged him with luke warm water. Temp is down to 99. Veteran still has some nausea but has been able to keep water and other  fluids down. Urine output is adequate.
Heart Cath 4/11/2023, Dr   1. Coronary artery disease as follows: 100% distal right coronary artery culprit lesion, 70% mid LAD, 70-80% distal LAD, 50% mid circumflex artery, 50-60% mid 1st obtuse marginal branch. 2. Successful PTCA stent mid right coronary artery with a 3.55 x 18 mm drug-eluting stent, successful PTCA stent distal right coronary artery/PDA with a 3 mm x 38 mm drug-eluting stent. 3. Mild LV dysfunction with ejection fraction of 45-50% with severe inferior apical hypokinesis. 4. No significant mitral regurgitation. 5. No aortic stenosis. 6. Mildly elevated left ventricular end-diastolic pressure of 20 mmHg.   Echo 4/11/2023 1. Left Ventricle: Left ventricle cavity appears normal. Wall thickness is normal. Systolic function is mildly decreased with an ejection fraction of 50 - 55%. Regional wall motion abnormalities present.  Inferior wall hypokinesia There is no diastolic dysfunction.   Hospital Course: Patient is a 71 year-old Male who presented via EMS due to complaints of crushing chest pain, Left arm pain, and diaphoresis  that started at 4/11 at 800 when he was raking the leaves. EKG in field significant for STEMI in inferior posterior aspect. In the ED, Vitals : 97.2F, 56 HR, 18 RR, 121/76, 97% RA, Labs significant for Trope 2120-- >2823, BNP 389 and positive Covid-19 test.  Patient admitted to cardiology team with emergent heart-cath. Heart cath performed by Dr showed complete RCA occlusion requiring 2x DES, notable 70% occlusion of mid LAD and 70-80% distal LAD, 50% mid circumflex and 0-60% obtuse marginal artery.  Echocardiogram obtained  showed EF of 50-55% with regional wall motion abnormalities, inferior wall hypokinesis with history of diastolic dysfunction.  Patient was initiated on DAPT: ASA and  Prasugrel, Lisinopril, and Metoprolol. Patients COVID symptoms remained stable with no significant symptomatology besides occasional cough. Pts hospital course not complicated and patient was discharged with instructions to follow-up with pcp, Cardiology while obtaining stress test and referral for cardiac rehab.
Case number PHEH2011US011840 is an initial spontaneous report received from a nurse on 15 Dec 2011: This report refers to a 29-year-old pregnant female patient. She was vaccinated (during pregnancy) with MENVEO vaccine (batch number: M10124) intramuscularly on 15 Dec 2011. No other adverse event was reported. 20 Nov 2012: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
red, raised/hard, itchy rash (Approx 4 inches in diameter) that is hot to the touch, appeared 13 days after the injection at the injection site
sick to her stomach; Feeling rotten; pain in leg; pain in knee/pain in joint/very painful from hip down to knee; tired all the time/still feels the same way; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043BZ1A and 028A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included AMLODIPINE, ATORVASTATIN, DICYCLOMINE [DICYCLOVERINE], METOPROLOL TARTRATE, OMEPRAZOLE and TRAMADOL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach) and FATIGUE (tired all the time/still feels the same way) had not resolved and FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg) and ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had contacted her doctor about it and received 2 shots of steroids in her hip 4 weeks. Patient had also taken Tramadol as treatment drug.
EXTREME THIRST.  WEAK IN LEGS. UNSTEADY. DISORIENTED.  5AM 8/10/2022; NEXT DAY - SAME AS ABOVE-LETHARGIC-TIRED; 8/11/2021 LETHARGIC, TIRED, CHILLY; FOR THE NEXT FEW WEEKS I FELT THE SAME STUMBLED,  OUT OF TOUCH WITH EVERYTHING; IT IS NOW 6-7 WEEKS LATER AND I STILL DO NOT FEEL ENTIRELY WELL. WEAKNESS IN LEGS. TIRED. LETHARGIC.
Covid19 breakthrough.  1st vaccine received on 06/29/2021.  38 y/o PMHx Diabetes, nonalcoholic steatohepatitis, atrophic kidney, megacolon, dysphagia with peg tube, DKA, resp distress presents to ED with bilat foot wounds that started 5 days ago.  CXR-low lung volumes with bibasilar opacities.  Febrile and room air sat 86%, placed on O2 at 3L NC-97%.  Pt started on IV Abx.
INTERMITTENT MUSCLE SORENESS. NO RASH OR VISIBLE REACTION AT ANY TIME.
Reported lip numbness, weird feeling in throat shortly after vaccine (past 15 min. observation period).  Lips remain numb today, the morning after. Also fever and body aches.
Post vax, pt experienced symptoms of bitter taste in mouth, fever/chills and sore arm with swelling.
A physician reported that a 26 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/20/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103.
Had  cold, followed by extreme fatigue in the weeks following the vaccine. Diagnosed with narcolepsy.
pt recvd flu vax & devel local swelling & warmth for 5 days;
arm swelled, ached, itched at site. Stomach hurt, soar muscles, NO rash
Information has been received from a 49 (currently 51) year old female patient concerning herself. Concomitant therapies included acyclovir. The patient did not have drug reactions and allergies. In November 2014 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route, lot# and expiration date were unknown), but right now the patient was experiencing shingles. She also reported that she took acyclovir to help with the shingles she had. The patient stated she was under stress, so she was not sure if this made her get shingles. The causality between ZOSTAVAX and the events was unknown.  Additional information has been requested.
Patient was given dose #1 at a vaccine community clinic on Friday. There were no reports of him being ill. Parents were present at the time of the vaccine. He went to school on Monday and had a seizure and was transported to hospital. He was placed on life support and was unresponsive. He began improving and was taken of life support on Wednesday and was discharged after a few days.
After receiving the Zoster vaccine, SHINGRIX, Feb. 21st, I developed fever 101, which lasted 8-10 hours, chills, headache, muscle aches, joint pain, and extreme fatigue. I had to call in sick Feb. 22 and I slept all day. I feel better today, Feb. 23.
Information has been received from an office manager concerning a 6 month old female with no medical history who on 07-AUG-2006 was vaccinated with a dose of RECOMBIVAX HB (lot # 651736/0672R), intramuscularly. Concomitant therapy that day included diphtheria toxoid/tetanus toxoid (lot # C2630AA) (IM) and PROHIBIT (lot # UE876AC) (IM). There was no illness at the time of vaccination. Subsequently the patient experienced unspecified adverse event. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.