chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A little chills) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (A little chills) and FATIGUE (Tiredness). At the time of the report, CHILLS (A little chills) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided. No treatments were provided.
Pt became very hot, light headed, nauseous, and almost passed out.  We sat her on the floor and checked pt's BP and monitored her until she felt better.  She refused emergency services and left on her own choice after she felt better.
Blanching petechial rash and swelling to left arm (arm of injection) and to right hand.
This spontaneous report was received from a nurse refers to a patient (reported as one of the 3 patients) of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 25/0.5 (unspecified units) (lot # K007262 and expiration date was 25-NOV-2015) dose 0.5 ml, intramuscular injection. Concomitant therapy was not reported. On an unknown date, the patient experienced severe muscle weakness, pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla, difficulty moving the injection site arm after receiving PNEUMOVAX 23. Patient was given ice to site. Patient sought medical attention by a physician visit. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Within 12 hours, pt noted non-tender redness, puffiness to the left arm around injection site. No heat to the area. Prescribed heat and advil.
Racing of heart; Stabbing in heart; Flutter once in a while; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Racing of heart) and CHEST PAIN (Stabbing in heart) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PALPITATIONS (Racing of heart) (seriousness criterion hospitalization), CHEST PAIN (Stabbing in heart) (seriousness criterion hospitalization) and CARDIAC FLUTTER (Flutter once in a while). The patient was hospitalized for 1 day due to CHEST PAIN and PALPITATIONS. They discharged her and told her to follow up with PCP. Her PCP did stress test and EKG on her and the results were normal. She did tell her PCP that she received the vaccine. She was not taking any medication before the possible adverse events. She was not started on any new medications after the vaccine. She is calling because the adverse events such as flutter once in a while, racing of heart are still ongoing. They happen occasionally.At the time of the report, PALPITATIONS (Racing of heart) and CARDIAC FLUTTER (Flutter once in a while) had not resolved and CHEST PAIN (Stabbing in heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Cardiac stress test: normal (normal) normal. In April 2021, Electrocardiogram: normal (normal) normal.         No relevant concomitant medications were reported.  On 01APR2021, the patient felt racing of heart and described the intensity as "stabbing in heart." Two weeks later she was hospitalized over night. The patient was not given any treatment or medications at the hospital and was told to follow-up with her PCP. Blood was drawn for 8 hours for lab work, the results of which were not provided.   This case was linked to MOD-2021-219135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Date of birth corrected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
THE PATIENT HAD A CUTE ALLERGIC REACTION AND DIFFICULTY TO BREATH. SHE HAD AN EPINEFRINE AUTO INJECTION, GOT RECOVERED IN 5-7 MINUTES
rt leg sterile abscess 1.7x2.2cm w/surrounding erythema, measuring 2.5x2.5cm, non-tender;no tx;currently has pneumonia unrelated to adverse event;
Anaphylactic reaction - severe stomach pain; tightening of throat; wheezing.
A vial was punctured, kept out at room temperature at 78-79 degrees Fahrenheit, and then administered to patients; Expired doses administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (A vial was punctured, kept out at room temperature at 78-79 degrees Fahrenheit, and then administered to patients) and EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (A vial was punctured, kept out at room temperature at 78-79 degrees Fahrenheit, and then administered to patients) and EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 06-Dec-2021, PRODUCT STORAGE ERROR (A vial was punctured, kept out at room temperature at 78-79 degrees Fahrenheit, and then administered to patients) and EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided  Excursion duration of 4 hours between when vaccines were administered and when vial was punctured. On 02-Dec-2021, vial was initially stored in the refrigerator and on 06-Dec-2021, vial was first punctured and administered.
This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received FLUARIX quadrivalent (batch number 3L9LD, expiry date 16th June 2016). In 2015, the patient received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX quadrivalent. Additional details were received as follows: The office reported 3 separate adverse events for the vaccine. The nurse reported 2 of the adverse events via fax to VAERS but did not report the 3rd event because of some type of non-traditional treatment. This case was linked with case US2015151593 and US2015151594, reported by the same reporter.
Severe never pain on both arm, hands and fingers.  Feeling dizziness most part of the day. Headaches and stomach problem
Potential dilution error. After dilution, enough doses were not able to drawn from vial which indicated enough diluent was not used.
Rash around injection site a few hours after injection. Rash then spread all over. Patient had a temp of 102 degrees.
Severe shoulder pain in area where flu shot was administered, limited range of motion, trouble sleeping (due to pain).  Attempted to treat with periodic ibruprofen until visit to primary care doctor one week later, followed by 2-week course of prescription NSAID.  Pain continues 6 weeks after vaccine administration.
Fever on 5/4 and 5/5 101F, nickel size redness and lump at injection site tender to touch.
COLD LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD LIKE SYMPTOMS) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced NASOPHARYNGITIS (COLD LIKE SYMPTOMS). At the time of the report, NASOPHARYNGITIS (COLD LIKE SYMPTOMS) had not resolved. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. No concomitant medication were reported. The reporters causality for the events of COLD LIKE SYMPTOMS with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Began feeling nauseated/weak, color very pale/white around mouth; BP 54/20 pulse very thready 60; put in prone position elevated feet & legs; w/in 11 min BP gradually progressively elevated to 96/50 pulse strong 80 reg;
4th vaccine given  90 days after 3rd vaccine. No reaction to vaccine. No treatment performed.
Immediate injection site reaction - swelling (golf-ball sized lump) at injection site with redness and warmth
neuropathy; myocarditis; pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) and MYOCARDITIS (myocarditis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and INCORRECT DOSE ADMINISTERED (pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), MYOCARDITIS (myocarditis) and INCORRECT DOSE ADMINISTERED (pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   A physician states that they have a patient who had myocarditis after getting the 1st 2 doses of the Moderna Covid-19 vaccine.  The patient was given the 1st dose and when the patient went back to the pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half. Physician does not had the vaccination details at the time of the call.  HCP states that these doses were given when the vaccines just came out.  HCP states that the patient was currently debilitated, had neuropathy and was having frequent PVCs.  He still had mild myocarditis and was saw a cardiologist. Concomitant medications were not reported.  No treatment medication was provided by the reporter. Company Comment This spontaneous case concerns a male patient of unknown age with no medical history reported who experienced the seriousness criterion medically significant expected event of myocarditis; and the seriousness criterion medically significant unexpected events of neuropathy peripheral and incorrect dose administered unknown days after 1st. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. He still had mild myocarditis and was saw a cardiologist. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Blackout and Had to go to Bed; Red From Shoulder to elbow; Intense itching From Shoulder to elbow; Mild Chills; Hard to the Touch; Swollen Injection Site.; Injection Site was Very Red (Golf Ball Size); Intense Itching 2-4" across on injection site; Muscle pain; A spontaneous report was received from a consumer concerning a 72-year-old female patients, who received Moderna's Covid 19 vaccine(mRNA1273) experienced muscle pain, itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site, mild chills, started blackout, itching and redness from shoulder to elbow.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 17 Feb 2021, prior to the onset of the symptom, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, approximately 2 hours prior to the onset of symptoms, the patient received second of two planned doses of mRNA-1273 (Batch Number: 41L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced muscle pain. On 19 Feb 2021, after two hours of vaccination, the patient experienced intense itching 2-4" across on injection site. Eight hours post second shot patient's injection site was very red (Golf Ball Size), hard to the touch and swollen. 25 hours after the injection patient developed mild chills followed by blackout and had to go bed, intense itching and redness from shoulder to elbow.   Treatment for the event included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events mild chills, started blackout, intense itching and was reported recovering. The outcome of the events itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site was reported recovered. The outcome of the events muscle pain, itching and redness from shoulder to elbow was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association, and the known safety profile of the  mRNA-1273  vaccine, a causal association between the reported events and the administration of vaccine cannot be excluded.
Patients mother states rash that comes and goes, started after receiving vaccination on 1/12/16. The mother took him to the Emergency Room on 1/13/16 and 1/14/16. Was treated with PRELORE and BENADRYL.
pt recvd vax immed exp chest pain which lasted 30 minutes & diaphoresis;
This case was reported by a physician via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGIRX. Concurrent medical conditions included connective tissue disorder. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced tenderness. On 31st March 2018, the patient experienced pain, erythema of extremities, joint pain and induration. On an unknown date, the patient experienced swelling, fatigue and headache. The patient was treated with prednisone (oral). On an unknown date, the outcome of the pain, swelling, fatigue, headache and tenderness were recovered/resolved and the outcome of the erythema of extremities, joint pain and induration were unknown. It was unknown if the reporter considered the pain, swelling, fatigue, erythema of extremities, headache, joint pain, induration and tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient and also a medical doctor. The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient woke up with severe joint pain and redness on her arm. Also, there was hard spot 6cm in diameter on her arm that was tender and there was redness around it but it was not fluctuant. The redness was not tender. Less than a month after receiving SHINGRIX, the patient also experienced headache and fatigue. The patient had a history of mixed connective tissue disease and the reaction felt like a major flare of this. Less than a month after receiving SHINGRIX, the patient's reaction looked like a local inflammatory response on her arm, but there were a lot of aches and pains elsewhere. The patient started taking Prednisone 10 mg per day and then began to wean it. It took a week for the redness and swelling to go away. She called back GlaxoSmithKline after receiving a voice mail with request to please callback from GlaxoSmithKline. She could not remember the exact day or time she left her original voicemail with GlaxoSmithKline. She was not watchin but thinks the product was administered intramuscularly into her left upper arm at the pharmacy. She was calling back GlaxoSmithKline to inquire whether or not she should continue with the vaccine series. She was transferred to medical information team regarding her current inquiry. Clarification has been raised for the confirmation of event local inflammatory response whether it was experienced by the patient after vaccination or not.
Painful breathing, coughing, fever, excess mucus production, vomiting/diarrhea 10 hours later feeling much better.
the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one dose of lot # S003865 with expiry date 08-AUG-2020 (frequency, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 32.5 Fahrenheit temperature for 8 hours. No previous temperature excursion was reported. Digital data logger was involved. The outcome of product storage error was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 26 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Chronic sinusitis" (unspecified if ongoing); "Non-CF bronchiectasis" (unspecified if ongoing), notes: Non-CF bronchiectasis. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Positive; (08Jan2023) Negative; (09Jan2023) Negative; (13Jan2023) Positive, notes: Tested positive immediately, woke up on 13Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. clinical course: Paxlovid given as covid19 treatment .Tested positive 03Jan on PCR Tested negative on rapids: 08Jan and 09Jan. No symptoms after completion of Paxlovid. However on 11Jan2023, started to have nasal discomfort and pressure. Thought it may be a sinus infection but I hadn't completed my 10-day quarantine. On 12Jan2023, sinus pressure increased until I lost my sense of smell for a few hours. Tested positive immediately, woke up on 13Jan with fatigue and chills once again.
515PM mom reported pt crying during afternoon observed pt x 30mins; T99.4 unconsolable crying called MD ofc-instructed to give APAP- to monitor temp q 4 hrs;to see MD in AM;give DT next visit;pt cont to scream-vomit x 2;
Itchy legs; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; Whole body was covered in rash/The rash appeared it started spreading to other parts of his body/Rash as red dots which were bumpy, raised, very itchy and some had popped; This spontaneous case was received on 09-Nov-2020 from other non-health professional via Med Communications (reference number: SEQW20-04943) and concerned a 42-year-old male patient.  The patient's medical history was not reported. The patient's concomitant medications included Zyrtec (cetirizine hydrochloride) for unreported indication.  On 04-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.  On an unspecified date in Oct-2020, within a week after receiving Afluria Quadrivalent, the patient started to get itchy legs, just above his knees.  On an unspecified date in Oct-2020, two days after the itch, the rash appeared it started spreading to other parts of his body. The patient described the rash as red dots which were bumpy, raised, very itchy and some had popped.  On an unspecified date in Oct-2020, the patient had seen his physician which provided him with antibiotics, doxycycline and steroid topical cream which did not work for him. The patient also had taken six Benadryl (diphenhydramine hydrochloride) tablets a day which did not do anything. Additionally, ice packs help. Furthermore, the patient had seen a dermatologist and was given a steroid injection. Lastly, the patient's physician has advised him to take an allergy test.  The outcome of the evet was not reported.  The reporter did not provide a causality assessment.  Company comment: The events of 'erythematous rash', 'raised rash', 'itchy rash' and 'pruritus' are considered as related to Afluria Quadrivalent vaccine.; Sender's Comments: The events of 'erythematous rash', 'raised rash', 'itchy rash' and 'pruritus' are considered as related to Afluria Quadrivalent vaccine.
I awoke 12-15 hours after injection with rapid heartbeat (145-150 bpm)(fitbit), and a temperature that was 6 degrees above normal. I took ibuprophen and temperature got down closer to normal in next 12 hours. heartbeat also returned to normal resting state (60-70bpm). Additionally it appears to have triggered a shingles outbreak as I now have new blisters in my scalp.
presented to EC with fatigue, inability to tolerate oral intake and melena and heamatochaezia, suffering constipation for 2-3 days, found to be tachycardic, admitted with planned EGD, remains in the hospital at time of this VAERS entry
Patient came in on 10/26/20 stating that she still has pain in her arm, where she received her Flu Shot.  She said that anytime she moves it, she has pain.  She also stated that she noticed the pain, right after the shot was administered and it has not gotten any better in 18 days.