chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- had anthrax vaccine on 29 April 2019 in medical clinic, administered to R deltoid; a day or two later noticed small red blotches distal to the deltoid insertion on his upper arm, that coalesced 1 day later into an erythematous, TTP, warm patch; no redness overlying the deltoid; no fever; no previous reaction to this vaccine (has had multiple doses over the years) - did notice a possible insect bite or bump inside the area of redness yesterday (mid upper arm) - on exam: R lateral upper arm: 12x7cm warm and TTP region of erythema and edema. Distal to deltoid insertion, with small 2mm papule within the circular skin lesion (anteroinferior aspect of the erythema, mid upper arm, not at typical deltoid injection site for vaccine). Skin at injection site well healed with no surounding erythema or TTP. No purulence/fluctance/drainage noted. -exam seemed consistent with mild cellulitis; however, was unclear if related to his recent Anthrax vaccine as erythema/edema distal to deltoid with no erythema or TTP tracking from this site. Had possible insect bite in the affected region of the upper arm, which may have been a more likely contributing factor. treated with Kelfex 500mg PO qid for 5 days  - on follow-up 48hrs later, reports redness has faded and receded from previous borders marked (with exception that it initially extended slightly beyond the inferior border (but has since been fading); pain improved - instructed to complete the 5 day course and Allergy consultation via teleconsult service - per Allergy, given the patient?s prior doses of Anthrax vaccine and the timing of onset as well as the appearance of the area of erythema, they suspected a local, robust inflammatory reaction (not IgE mediated) and the movement down the arm was likely related to dependent effects
I mistakenly gave the client the diluent only for the 2 vial formulation of Menveo, not adding the powdered vaccine. It was dose 2 for the client. The client was called on 8/21/23 to report the mistake. A message was left with the client and he returned the call later that evening. The client had no adverse reaction. The outcome/treatment will be to repeat dose 2 of the Menveo series when he comes in to have dose 2 of Men B. The client will be home in November and the series will both be completed at that time
really bad nose bleeds after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "really bad nose bleeds after the booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upper GI bleed Supratherapeutic INR Gastrointestinal hemorrhage with melena Symptomatic anemia dizzy Melena
Vaccine appointment; injection in right arm; no immediate or delayed symptoms over 7 day course.
This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose and lot# not reported) subcutaneous. The patient received his second dose of GARDASIL (dose and lot# not reported) approximately 2 years after he received his first dose in the series. No adverse effect reported. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
pt recv vax 12JUN95 & 31DEC96 pt devel a breakthrough case of chicken pox rash consisting of 35 varicella-like lesions scattered on extremities, abd, face, trunk, buttocks;
Approximately 1 week after my 2nd dose, I developed an extreme tinnitus in my left ear and it was really getting out of hand and I had to make an appointment with Doctor and at the time I said it was much worse than it has been in the past. I've been experiencing high pitch noise than usual and ringing (left ear specifically), after I went to see Doctor there was no treatment given to me and I was advised to return after 3 months if it gets worse and up to this day I still have it - still consistently the same as I had it after my 2nd shot.
Seen on 4/28/2000 with redness at site of injection, measuring 5" in length and 2" in width and warm to touch. Treatment with Tylenol and warm compresses.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2021 ANEMIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/26/2021 ANEMIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/30/2021 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/26/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/30/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2021 HEMOPTYSIS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/26/2021 HEMOPTYSIS J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/30/2021 HEMOPTYSIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/20/2021 PNEUMONIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/26/2021 PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/30/2021 PNEUMONIA
While napping, patient was breathing really oddly. It sounded like wheezing almost. Patient has had a respiratory virus for a few weeks, but has not had breathing like this until after her appoimtment. I called the pediatrician's office, they described what concerning breathing would look like, and it did not fit the description. They told me to monitor her breathing, and tonight she sounds the same as well.
Initial and follow-up information has been received from a certified medical assistant for the pregnancy registry for GARDASIL concerning a 22 year old female who on 21-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL (658490/0802U). Subsequently, the patient discovered that she was pregnant (LMP=10-AUG-2007). The patient returned to the physician's office on 05-DEC-2007 because her cycle was late and the office performed a pregnancy test that was positive. During the 05-DEC-2007 office visit, the patient was asked to have an ultrasound obtained. The patient was seen in the office again on 26-DEC-2007 and had not yet had the ultrasound completed. The scheduled date for the ultrasound was unknown. Per the reporter, the pregnancy has been unremarkable thus far. No additional information was available. Patient outcome was not reported. Follow up information received on 13-MAR-2009 from an initial and an outcome pregnancy questionnaire stated that the patient had no concurrent medical conditions reported. Medication used during the pregnancy includes ZOFRAN in January 2008 through February for the treatment of nausea. The patient was also taken prenatal vitamins. There were not birth defects and infant complications in previous pregnancies, the patient had a previous full term delivery and no fetal deaths, spontaneous abortions and pre term deliveries. The patient had an elective pregnancy termination in May 2007 at 7 weeks from LMP. The products of the conception were examined. The patient did not experience infections or illness during pregnancy. The patient had an ultrasound and a serum alpha-fetoprotein test (MSAFP), both were normal. Upon internal review, elective termination was determined to be an other important medical event. No further information is available.
injected air; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (injected air) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (injected air). On 16-Mar-2021, DEVICE CONNECTION ISSUE (injected air) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (lot#, expiry date, dose, route unspecified), that was stored improperly. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful; I had a little neuropathy and it is much worse, correct. It has never been this bad; I am having an unusual terrible reaction; unbelievably horrible nightmares; Nightmares are unbelievably horrific; Seems to be affecting my urine; neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had a little neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), PAIN (non-serious), outcome "unknown" and all described as "neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "I had a little neuropathy and it is much worse, correct. It has never been this bad"; NIGHTMARE (non-serious), outcome "unknown", described as "I am having an unusual terrible reaction; unbelievably horrible nightmares; Nightmares are unbelievably horrific"; URINE ANALYSIS ABNORMAL (non-serious), outcome "unknown", described as "Seems to be affecting my urine". The patient underwent the following laboratory tests and procedures: Urine analysis: It seems to be affecting my urine. Clinical course: Consumer stated, I just took the COVID vaccine and I am having an unusual terrible reaction. I am having unbelievably horrible nightmares. It seems to be affecting my urine. I also have an advance case of neuropathy and my neuropathy is all terrible, extremely painful and they said the dreams, the nightmares are unbelievably horrific. I have never had any like this in my life. When paraphrased the above concern, consumer stated, Neuropathy, my feet is much much worse. I had a little neuropathy and it is much worse, correct. It has never been this bad, very painful and the nightmares on the other hand, horrific nightmares.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report has received from a registered nurse referring to a 41 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-OCT-2017, the patient was vaccinated with a pediatric dose of VAQTA second dose (strength, route of administration were not provided) lot # M033611, expiration date 02-MAR-2018, for prophylaxis. No adverse reactions reported.
patient fainted and started seizing.  seizure lasted approximately 30 seconds.  we laid the patient out on the floor and  called to him and he came around quickly.  we kept him on the floor and removed his jacket, put a cool rag on his head.  he was coherent and responsive.  we called 911 and the paramedics came and evaluated him and sent him home with his parents
Two months post vax the pt experienced fatigue and developed a sinus infection which required a doctor or ER visit. She was treated with amoxicillin. Her symptoms including fever were self-limiting. The infection cleared up one week after the antibiotic finished. It then resumed and continued until mid-November. Fatigue was apparent for two months. Additionally, the pt developed anemia. The most recent information received reports the condition of the pt is unknown.
felt her heart racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Apr2021, outcome "unknown", described as "felt her heart racing". The event "felt her heart racing" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to ER in Apr2021 after 1st dose of Pfizer, felt her heart racing, they could not find anything wrong and her 2nd dose she was fine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I broke out in an itchy rash on my thighs, buttocks, legs and arms on the Sunday after my vaccination.  One week later, I still have it but it is not as itchy or as irritating as it was originally.
Rash all over upper torso that did not itch. I went to a clinic on 6/16/21 and was told that it was probably pityriasis rosea, a common and harmless rash. However, it keeps spreading and is now going up my neck.
Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year; Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Panful arm for 1 day but starting 24 hours after vaccine I have had flu like symptoms- lethargy, body aches, headache, plugged ears
Severe body and joint pains, fatigue.  Woke up at 1:30 am with severe body and joint pain and lasted all day.   Pain was very similar to the joint and body pain I had when I had Covid.  I was in bed the entire day but felt better the next day, just a little tired.  Took Ibprophin and Tylenol for pain.
Inability to focus thinking; Sore arm around injection site; tired; sneezing; This is a spontaneous report from a contactable Pharmacist (parent). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular route of administration in right arm on 20Mar2021 at 16:00 (at the age of 26-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history was not reported. Concomitant medications included loratadine taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported; birth control pill taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. The patient experienced sore arm around injection site, tired on 21Mar2021 at 20:00, sneezing on 21Mar2021 and inability to focus thinking on 22Mar2021 at 10:30. The ice and acetaminophen were given as treatment for soreness. The outcome of sore arm around injection site, tired, sneezing was resolving and inability to focus thinking was resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender with immunosuppression (unspecified medical condition) who several years ago on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The physician reported that he saw the patient who was given ZOSTAVAX and the patient eventually experienced multiple organ failure. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for multi organ failure and ZOSTAVAX was unknown. Upon internal review multi-organ failure was considered to be medically significant. Additional information has been requested.
Chills all day the day after my vaccine, slept approx. 16-18 hrs the following day, injection site was sore and firm for 3 days after.
PATIENT DEVELOPED A RASH THAT RESOLVED AFTER A FEW DAYS. PATIENT ALSO GOT A FLUAD INFLUENZA VACCINE THE SAME DAY BUT IN THE OTHER ARM. THE RASH OCCURRED IN THE LEFT ARM WHERE THE PNEUMOVAX WAS ADMINISTERED.
Information has been received from an ER physician and a nurse in a pediatrician's office concerning a 4 year old male with no known allergies who was noted to be a normal healthy child without immunosuppression. On 5/3/01, the pt was vaccinated with 1 dose of varicella virus vaccine live (site unknown). Concomitant vaccinations that same day included 1 dose of MMRII. Other vaccinations that day included, 1 dose of diphtheria toxoid/pertussis vaccine/teta and 1 dose of poliovirus vaccine. On 5/7/01, the pt developed a herpes zoster-like rash at the site of the varicella virus vaccine live injection. On 5/10/01, the physician reported that the rash "now" involved the chest, armpit area and a small area on the back. It was also reported that the child had some lesions on the right arm and right chest. The rash was slightly itchy. The pt had no fever and otherwise felt fine. The pt was seen in the ER and treated with acyclovir (Zovirax) and was released from the ER with the child to see his pediatrician 2 days later. A nurse in the pt's pediatrician's office stated that the pediatrician agreed with the dx of herpes zoster and described the herpes zoster along the right T4 dermatome. In addition to the Zovirax, the pt was treated with cetirizine hydrochloride (Zyrtec) and prophylactically with Zithromax. It was noted that the pt did have itching and pain. The nurse planned to contact the pt's mother to discover if any dried lesions were available and will also attempt to obtain information about previous exposure to wild type virus. The nurse was unable to provide lot numbers for the varicella virus vaccine live or the MMRII that the pt received because they were not given at this office. Additional information has been requested.
Narrative:  67 y/o male, received first dose of COVID-19 vaccine (Pfizer) on 3/5/2021. Daughter called medical facility 3/22/2021 requesting to speak with PCP to inform that pt was admitted to hospital diagnosed w/ MI and needed to know if pt had DNR. Patient expired 3/26/2021.
Swollen lymph node in the neck on the left side; This is a spontaneous report from a contactable Consumer. This 38-year-old Female Consumer (patient) reported that:  This is a spontaneous report from a contactable consumer or other non hcp. A 38-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, milk allergy known allergies Milk, doxycycline. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug hypersensitivity. The patient experienced swollen lymph node in the neck on the left side on 21Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
"...rash for 3 days, red, hot, down her arm. She just used ice and it went away."
Complaints of severe deltoid/biceps muscle pain and c/o severe, deep pain when extending left arm laterally and above shoulder level. States Tylenol does not help pain.
First Shot 3/26/2021 - Middle of night woke up with a portion of my tongue on the right side tip was numb.  Like a line - from the middle of my tongue wrapping to the bottom of my tongue.  I could feel my tongue on either side of the "numb streak/line" It eventually went away after 4-7 days  SECOND SHOT 4/16/2021 - AT 1:30PM 4/17/2021 STARTED GETTING DIZZY AND SICK.  4/18/2021 WOKE UP AND EXTREMELY STIFF.  4/19/2021 HURTING AND COULD HARDLY MOVE MY SHOULDERS, NECK OR LEG JOINTS.  FIGURED IT WAS THE SHOT AND WOULD PASS.  APRIL 26, 2021 IN EXTREME PAIN TRIED TO SEE DOC-TOLD ME TO GO TO A NEIGHBORHOOD WALKIN CLINIC-THEY WOULDN'T TAKE ME SAYING I HAD SOFT TISSUE PROB AND COULDN'T HELP ME. IN SO MUCH PAIN CRYING AND COUL  HARDLY WALK OR MOVE. DAUGHTER HAD TO DRIVE ME. WENT TO DOC AT NOON 4/27/21 GAVE ME ANTIFLAMATORY. I SIAD THIS IS THE SHOT HE SAID HE DOUBTED IT.  CONTINUED TO WORSEN TRIED STRETCHING, ANTIFLAMATORIES AND NO HELP. WASN'T SURE I WANTED TO GO TO A RHEUMETOID OR NEUROLOGIST. CHOSE RHEUMETOID DOC. ASKED IF I HAD MY ANTIBOTIES CHECKED BEFORE THE SHOT(S). i SAID NO - NO ONE SUGGESTED THAT. SAID I HAD/HAVE PMR (POLYMAYALGIA RHUEMETICA). THIS DESCRIBE DIAGNOSIS DESCRIBES EXACTLY WHAT STARTED ON 4/18/21. IF YOU CUT OFF MY HEAD JUST ABOVE MY NECK, MY ARMS JUST BELOW MY SHOULDER JOINT AND LEGS JUST BELOW MY LEG JOINTS WHAT IS LEFT IS WHAT WAS IN SERIOUS PAIN. STEROIDS (PREDISONE) WAS PRESCRIBED.  IT IS NOW 10/4/2021 AND I STILL HAVE PAIN IN THESE JOINTS. NO ONE WILL EVERY CONVINCE ME IT WAS NOT THE SHOT. I WAS HEALTHY, NO PAIN UNTIL AFTER THE 2ND SHOT (WITHIN 2 DAYS I WAS IN PAIN AND HAD DIFFICULTY WITH THE ABOVE DESCRIBED JOINTS).  EVEN IF I MIGHT HAVE PMR 10-15 YEARS DOWN THE LINE - THAT'S ONE THING. IT WAS STIMULATED AND CAUSED BY THE SHOT.