chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High Troponin Levels; Felt dizzy; Chest felt tight; Mitral valve filling defect; Difficulty breathing; Concern of anaphylaxis; Passed out unconscious; A spontaneous report was received from a physician concerning an approximately 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect.  The patient's medical history as provided by the reporter included a history of anxiety. Concomitant medication use included sertraline, buspirone, acyclovir, propranolol, hydroxyzine and lorazepam for unknown indications.  On 04 Jan 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021) intramuscularly, in her left deltoid, for prophylaxis of COVID-19 infection.   On 04 Jan 2020, a couple of minutes after receiving the vaccine, the patient experienced dizziness, chest felt tight, difficulty breathing, and she passed out unconscious. Due to concern of anaphylaxis, while the patient was still unconscious, she was treated with epinephrine followed by intramuscular injection of cetirizine hydrochloride. In addition, ammonia salt was used. The patient woke up briefly and passed back out. Emergency medical services (EMS) arrived and almost had to intubate the patient. The patient stayed overnight in the hospital due to lab values indicating non-ST segment elevation myocardial infraction, high troponin levels, and a mitral valve filing defect. It was noted that the patient has never had an allergy to anything, including the excipients in the Moderna vaccine. In addition, the patient had no history of loss of consciousness or anaphylaxis. Relevant laboratory tests conducted included an echocardiogram which found no issues with cardiac function and noted a mitral valve filling defect.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect was unknown.; Reporter's Comments: This case concerns a 28 year old female patient with medical history anxiety who experienced Concern of anaphylaxis , high troponin levels, dizziness, chest discomfort, difficulty breathing, loss of consciousness and Mitral valve filling defect  same day after administration of the first and only dose of the mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021).  Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.
Complained of pain in left arm then pain developed in all the joints. States hand hurt to point could not turn a door knob. Pain began 2 days after HIB vaccine given in left deltoid.
From the 18 and up vials; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT USE ISSUE (From the 18 and up vials) in a 2-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milligram. On 11-Jul-2022, the patient experienced PRODUCT USE ISSUE (From the 18 and up vials). At the time of the report, PRODUCT USE ISSUE (From the 18 and up vials) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The vaccine was given from the vial with a red cap and light blue label border No treatment information was provided by the reporter.
Maculopapular rash w/urticaria on trunk, extremities, soles of feet, & face; facial swelling, petechiae on feet 5 days p/vax 12AUG91;
pt recv vax 1AUG97 & pt exp an itchy rash on most of body & a temp of 100 approx 3 days p/vax;the outcome of the sx is currently unk but redness of rash seems to be dec;
Reporting an adverse event with the Covd-19 Vaccine; received the Covd-19 Vaccine and leukemia is gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Reporting an adverse event with the Covd-19 Vaccine; received the Covd-19 Vaccine and leukemia is gone". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following the Moderna booster, I had the usual sore arm and feeling under the weather for a day or two. However, on 11/11 I developed a chronic uticaria with pruritis that I have had everyday since 11/11. I get hives and severI have not e itching that occurs daily and the location seems to migrate day to day. The itching is severe and the only thing that seems to calm it down is Benadryl 25 mg or sometimes 50 mg. I have not changed anything with my diet or in my environment that I can connect this to. I also was put on a taper dose of Predisone which did not seem to help at all. I am still getting this chronic uticaria and pruritis daily.
10 days after injection,  3.5 cm round rash; erythematous and raised.
1/27/21 approx. 1700, chills, headache, fever 101.1, body aches. 1/28/21 0230-chills, severe body aches, muscle pain, fever 102.6, 0400-chills, body aches, muscle pain, fever 103.1, 1130am-muscle aches, fever 101.0. Muscle aches all day, approx. 1900-temp 99.8. 1/29/21 0400-hives throughout the entire body, red rash, severe itching, temp 101.6, no more body aches, chills or headache. Started steriods 0700 on 1/30/21, hives resolved, rash remains over entire body.
Information has been received from a registered nurse concerning a 11 year old female with no known drug allergies and no past medical history who on 07/02/1996 was vaccinated with varicella vaccine. There was no concomitant medication. On 12/04/2001, the pt developed a low grade fever and a mild case of chicken pox. It was reported that the pox were located on her back, face and chest. The exact number of lesions was unknown. Unspecified medical attention was sought. The child subsequently recovered from the chicken pox. The nurse also reported that the 6 year old sister of this pt also developed chicken pox following vaccination with varicella vaccine (WAES01120804). Additional info has been requested.
10/19/2021 Experienced tightness with heart within 7 days of Janssen Covid shot.    10/28/2021 ECG performed and blood work was drawn.  Results of blood work detected high Troponin which is a result of previous heart attack or myocarditis.  11/01/2021 ECHO Transthoracic performed.  11/24/2021 ECHO Stress Test performed.
EFFECT STARTED COUPLE DAYS AFTER VACCINATION. SORENESS OF BOTH ARMS, TINGLING RADIATING TO NECK AND BACK AND BACK TO HEAD. CAN'T LIFT.
Initial and follow-up information has been received from a pharmacist concerning a 65 year old male with no relevant medical history or allergies who on 18-JUN-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot number 659408/300X) by subcutaneous injection in the left deltoid. There was no concomitant medication. On 01-JUL-2008, also reported as "a couple of days", the patient developed a herpes form blister at the injection site, which scabbed over after blister broke. After accidental arm contacted, the blister was painless. The patient applied NEOSPORIN to the rash. The patient's outcome was unknown. Additional information is not expected.
I was exposed to Covid 19 from my husband who had exposure from someone who came home from a vacation. He gave it to my husband and I picked it up from my husband.
VASOVAGAL SYNCOPE WHILE STANDING TO GET VACCINE CARD CHECKED/FELL ON THE GROUND FOR 5 SECS, PT DID NOT INJURE HIMSELF. PARAMEDIC CAME, SYMPTOMS RESOLVED, NO TRANSPORT, LEFT WITH WIFE.
We received from a physician via Sanofi Pasteur and the Medical agency the following information on 15 JAN 2008: A 55-year-old woman, born on 03 SEP 1952, diagnosed in SEP 2007 with a stage III gastric carcinoma and a status post partial gastrectomy with lymph node dissection, was vaccinated with Fluvirin, batch-no. 78479, i.m. into the left arm on 07 NOV 2007. She had been doing well with her nutrition as an outpatient. Two hours after the vaccination (after 3-4 hours was also reported) the patient suffered from nausea and excessive salivation with vomiting which intensified and led to dehydration and malnutrition. She was admitted to the hospital from 12 NOV-23 NOV 2007 to initial total parenteral nutrition (TPN) and to evaluate to cause for her symptoms. CT scans of the chest, abdomen and pelvis were performed which showed no evidence of recurrence of her cancer. She had an upper GI endoscopy which showed evidence of bile acid reflux with significant esophagitis and no definite evidence of recurrence of tumor and no evidence of stricture at the surgical anastomotic site. It was felt that the patient's nausea and vomiting was predominantly due to bile acid reflux following her recent surgery. She was initially treated with Carafate (sucralfate), high dose Protonix (pantoprazole) and intravenous Reglan (metoclopramide). With this, there was some modest improvement in her nausea and vomiting. Condition on discharge: improved with only mild nausea and vomiting. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated, due to biliary reflux following her recent partial gastrectomy. Expectedness assessment according to manufacturer label: The reported symptoms are due to the persistent symptomatic not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measure necessary. Agency-no. NA08-000162 Sanofi Pasteur no.: 2007-03865 (0)
Patient received her Covid vaccine and had a sudden onset of burning sensation in the epigastric region .  She denied shortness of breath, nausea or vomiting.  She did have some facial flushing.
Information has been received from a Nurse practitioner concerning a 66 year old female patient who on 01-FEB-2007 was vaccinated with her first dose of Pneumovax 23, lot #655285/1173F.  The patient developed an injection site reaction described as redness, swelling, heat and pain from the elbow up after receiving Pneumovax 23.  The development and duration of the reaction were not clear, the patient was not observed in the office but sought medical attention.  As of the report date, the patient had recovered.  The reporter indicated that two other patients had developed injection site reactions after receiving Pneumovax 23.  Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010465, expiry date: 23-MAR-2016) (route: intramuscular). The patient has not experienced an adverse effect. The outcome of the events was unknown. Additional information has been requested.
Numbness and tingling all the way from injection site to the pinky and ring fingers foe few days. Nausea since injection off and on.
Red bumps/rash covering legs. Next day (1/9/16) spread to arms with fever, cough, runny nose, lack of appetite, fatigue. 1/11/16, idiopathic thrombocytopenic purpura shows up on legs, arms, and face and continuation of all other symptoms.
Bumps/ felt like bumps on buttocks and she saw more on her foot.; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of sciatica (for 1st dose refer case US2020AMR082346). Concurrent medical conditions included sciatic neuralgia.   On 30th April 2020, the patient received the 2nd dose of Shingrix. On 5th May 2020, 5 days after receiving Shingrix, the patient experienced shingles. On 8th May 2020, the patient experienced swelling. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the shingles and swelling to be related to Shingrix.  Additional details were reported as follows: On 26th April 2020, patient was working outside and strained her sciatica. On 30th April 2020, she got the 2nd dose of Shingrix. On 4th May 2020, she was in a pain still from straining her sciatica and and she went to her chiropractor. On the night of 4th May 2020, she could not laid down on bed from the pain and slept on the floor. She woke up the next morning with what she thought were spider bites in ankle.  On 5th May 2020, she slept on the floor again, and she woke up with what she thought it was spider bites on her right knee. It was kind of following the sciatic nerve.  On 8th May 2020, patient noticed what felt like bumps on buttocks and she saw more on her foot. Patient told it was following the path of the sciatic nerve. The patient visited her physician and was diagnosed with shingles. Patient confirmed she did not have spider bites. It was shingles. She was being put on medication, but she was still not recovered from shingles. The patient did not have previous history of shingles. The reporter consented to follow up. This case has been linked with US2020AMR082346, reported by same reporter.
93 yo M hx of HLD HTN RBBB presenting with weakness and feeling dehydrated.  Patient had received covid-19 shot and was unable to walk to his car (200 ft), because he was weak.  Asked another patient for help and they alerted staff, who wheeled him to the ED.  Patient initially declining any intervention, not in pain, or mental confusion. Vital signs mostly normal, elevated heart rate, ran ekg and tropinin  Patient Sent to cardiac unit at local Hospital then transferred to another HCF for stent
tingling; numbness; pain in my arm; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves Adult patient (unknown gender) who had tingling (paraesthesia), numbness (hypoaesthesia) and pain in my arm (pain in extremity) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious tingling (paraesthesia), numbness (hypoaesthesia) and pain in my arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Had a flu shot three years ago had tingling, numbness and pain in my arm for three months. Doctor (Dr) said I must be allergic."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the events.  There will be no information on the batch number for this case.
No additional AE; temperature excursion; This spontaneous report was received from an office manager (described also as an healthcare professional (HCP)) and refers to a 9-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 07-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant) thimerosal free (RECOMBIVAX HB) lot # T004378, expiration date 01-NOV-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a following temperatures: 49.7 degrees Fahrenheit (F) for 1 hour, 33.9 F for 15 hours, 35.1 F for 30 minutes, 47 F for 20 minutes, 35.5 F for 1 hour and 35 F for 1 hour. No previous temperature excursion occurred. Digital data logger was not involved. No adverse event (AE) was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA004929:
RN on 6/30/98 was squirted in both eyes w/MMR vax;pt devel redness & burning bilat;p/20min of irrigation eyes were sl red;pt was evaluated by MD;
The first two days of the vaccine I had fatigue and intermittent sore throat. I did not have the energy to exercise or finish home tasks at home. I had to rest.   One week later 1/20/2021, I got a big red rash approximately 2 inches circular around the area, the skin is slightly lifted "swelling", it is itchy and it is slightly painful to the touch. When I touch it, it feels very tough and not soft compared to my right arm.
This spontaneous report was received from a consumer refers to a 12 year old male patient who is her son. No medical history or drug allergies were reported. On 01-OCT-2013, the patient was vaccinated with dose 2 of GARDASIL (lot # J007354, expiry- 20-FEB-2016). No concomitant medications were reported. She stated that she received a letter from the office where it was administered that her son had received a dose of the recalled lot of GARDASIL. She reported that her son had an injection site reaction, which was red and swollen. She stated that she did not seek treatment for the reaction, but used "hot and col compresses" and the swelling resolved "in a few days". No laboratory tests were performed. She stated that he did not have any injection site reaction to his first injection of GARDASIL. The relatedness of the event to GARDASIL was unknown. No PQC involved. Additional information is not expected.
patient inadvertently received an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-month-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Infanrix. On 25-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received an expired dose of Infanrix).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient inadvertently received an expired dose of Infanrix, which led to expired vaccine used. The reporter consented to follow up.
Swelling of the upper lip. no itching.   Had Covid 10 Booster, Moderna, at pharmacy 11/18/2021.   Swelling of the lip happened after this, lasted a short time and resolved however a couple days ago (12/18) it did return and has lasted at least 2 days. She has not tried any medications previously, however took a benadryl after calling the office before coming here (Visit with me on December 20).  Notes she ate variety of things prior to this happening, some chips and crackers, ect.  Not sure if the food is related.  No difficulty breathing or swelling of the throat or tongue.   Gave antihistamine and Prednisone.  Symptoms improving.  Started ZyrTEC Childrens Allergy 5 MG/5ML Oral Solution, 10 Milliliter daily, 140 Milliliter, 14 days starting 12/21/2021, Ref. x4. Started predniSONE 5 MG (21) Oral Tablet Therapy Pack, 1 (one) Tab Ther Pack as directed, 1 Blister, 6 days starting 12/21/2021, No Refill.  Pharmacist Notes: * 6 Day Dose Pack * instruct to crush pills and have her mix with yogurt or applesauce
w/in 2 hr of vax pt devel redness & swelling @ the inj site & swelling of the lt hand;redness & swelling @ the inj site have resolved but the hand remained swollen @ the date of this report;
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical histories, drug reactions and allergies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L009209, expiration date 17-SEP-2016; lot # L003222, expiration date 30-JUL-2016: lot#K023861, expiration date 25-MAY-2016; doses, routes and sites of administration were not reported). No adverse events were reported. There was no product quality complaints (PQC) were involved. This is one of several reports received from the same reporter. Additional information has been requested.
30 min after vaccine - had tingling of hands/feet (history of this in past not pertaining to vaccine) approx 1 1/2 hours after vaccine had sensation of throat fullness/tightness - took 50mg of Benadryl and called health center who advised immediate evaluation.  At the time I saw her (almost 3 hours from time of vaccine) - she had some erythema at injection site otherwise I saw no identifiable urticaria, stridor,  oropharyngeal edema.  VSS and physical exam otherwise normal.
As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine.  A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close.  Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall.  All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry.  I quickly moved over to the side lane still inside of amusement park and waited.  I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry.  I waiting another 15 minutes before driving home.  That evening the blurriness came back, my eye's & forehead was tender to touch but no headache.  Only pressure in my head.  My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th.  As of today, no other systems other than feeling my body has inflammation.