chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of fever in a 11 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On an unspecified date, the patient received an injection of Infanrix, which is not recommended for immunizing individuals 7 years of age or older. On 9/10/03, at an unspecified time post immunization, the patient's parent telephoned the physician to report that the patient was experiencing fever, malaise, and an injection site reaction characterized by redness, swelling, and induration. The events resolved on an unspecified date prior to 9/17/03.
Approximately 3-4 hours post vax the pt developed pallor and excessive crying for 1-2 hours.
Started to sweat and get dizzy, lightheaded,  things started to get black and my throat started closing.  This all lasted for about 7 minutes.
fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.
Moderna COVID-19 Vaccine EUA: patient hospitalized with acute hypoxemic respiratory insufficiency, atrial fibrillation, acute kidney injury with metabolic acidosis, and a hypercoagulable state. Received remdesivir, anticoagulation, electrolytes, and steroids. Discharged to home medically stable.
No reaction, however patient was only 17 years and 7 months old at administration time.
got the shot, had shingles/ Suspected vaccination failure; shingles internally; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got shots and since then had bad pain. The reporter stated that, had shingles before had pain. The reporter asked to physician,if it was possible to have shingles with out rash or blisters.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
5SEP91 undocumented temp p/immun; 6SEP91 0800 raised blotches noted on rt arm down from inject site; sl tender to touch, sl swelling, t99.4;
Pt. states that after receiving the 2nd dose of Moderna 07/10/2021, started experiencing symptoms 07/13/2021 of shortness of breath, heart palpations, weakness, and throbbing through the back. ER visit 07/17th,20th, 23rd/2021, acute-pericarditis sent home with 600mg Ibuprofen
04/22/15 - Redness and itching at injection site. 04/24/15 - Continued redness and itching at injection site, no worse/no better. 04/27/15 - Itching on chest, back, and scalp. R eye swelling and redness. Injection site also red, hot, itchy, and swollen still. Single lesion on right cheek. Referred to ophtho who confirmed diagnosis of shingles likely due to Zostavax. Given valtrex.
pt recv vax 21SEP98 & returns 23SEP98 w/urticaria;
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
With in 30 minutes of administration of vax arm at injection site became blotchy red and itchy
red blotches on her cheeks; itchy cheeks; itchy arm; arm was red/red band from one side to the other; knot at the injection site; arm was painful/arm started to hurt worse; left arm from shoulder to tips of fingers has nerve pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was painful/arm started to hurt worse), ERYTHEMA (arm was red/red band from one side to the other), VACCINATION SITE NODULE (knot at the injection site), RASH MACULAR (red blotches on her cheeks) and PRURITUS (itchy cheeks) in a 63-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.     Concomitant products included MELOXICAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was painful/arm started to hurt worse) and NEURALGIA (left arm from shoulder to tips of fingers has nerve pain). On 18-Mar-2021, the patient experienced VACCINATION SITE NODULE (knot at the injection site). On 26-Mar-2021, the patient experienced ERYTHEMA (arm was red/red band from one side to the other). On 28-Mar-2021, the patient experienced RASH MACULAR (red blotches on her cheeks), PRURITUS (itchy cheeks) and PRURITUS (itchy arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was painful/arm started to hurt worse), ERYTHEMA (arm was red/red band from one side to the other), VACCINATION SITE NODULE (knot at the injection site), RASH MACULAR (red blotches on her cheeks), PRURITUS (itchy cheeks), PRURITUS (itchy arm) and NEURALGIA (left arm from shoulder to tips of fingers has nerve pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       ice pack used by Patient as  Treatment
Left arm, deltoid area, red, swollen and itchy over about a 20mmX25mm area.  Treated with over the counter Benadryl, to return to clinic if worse or not resolved.
Two weeks post vax pt experienced 3 pox on arms. Nine weeks post vax pt experienced 2-3 pox on the arms. In September of 1999 he experienced 2 - 3 pox on the arms. Pt experienced a low grade fever with all three outbreaks. The pox weeped and dried 3 - 4 days after each outbreak.
Uncontrolled shaking; Dizziness; Stomach ache; A little fever; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin) and Food allergy (Shrimp). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021 at 10:00 AM, the patient experienced TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness). At the time of the report, TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness) had resolved.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-012995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up was received on 26-JUN-2021 contains No new Information
Ached very very badly. Skin hurt. Shortness of breath and very weak. No physician evaluation recorded with fluids received; heating pad for 5 days.
Based on documentation from case manager during case investigation interview, "CT stated they were visiting family up north when she started feeling ill." As of 7/8/2021 symptoms include headache, fatigue, loss of smell. Received SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay~SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay on 7/9/2021 and came back positive.
Initial unsolicited report received from a Healthcare professional on 19 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (from MDV) (batch number, dose in series route and site of administration were unknown and expiry date, dose were not reported) on an unknown date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination the patient's International normalized ratio (INR) went from 2.7 up to 5.9. Laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
extreme shortness of breathe, irregular heartbeat, fatigue, loss of bladder control, shooting pains, muscle ache, tightness in chest
pt recvd vax; urticaria several hr after vax; sz lasted 2-4 mins; lethargic 48 hr after vax;
3/2/21:  I noticed my face was red/flushed for about 4-5 hours beginning in the afternoon (@2:00 p.m.). After my shower in the evening (@8:00 p.m.), I noticed a swath of red on my left arm, approximately 4 inches by 2.5 inches.  It was well defined.  The swath was warm, slightly raised, but did not itch.  The swath of red remained but began to fade slightly after about 3 days, although it is still there today, 3/7/21.
Hyperactivity for a week, tremors, small but intense headaches that move from area to area around my skull (still have them, but they are better), weakness, dizziness (getting better), slurred speech,  (ok now), ongoing short-term fevers that come and go quickly.
Low grade fever(100.3), body aches, joint pain, rash, headache, swollen lymph nodes(left shoulder)
soreness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced arm soreness at site of injection that lasted about a day. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020AMR025547, reported by same reporter for the same patient.
Patient received vaccines 10/11/02. DPT and IPV left upper arm. Presented to ER 10/13/02.
vaccine had been expired when it was given; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA106109  This case involves a 45 years old female patient who was inadvertently vaccinated with an expired dose of 0.5 ml RABIES VACCINE[IMOVAX RABIES] lot N1B902M via unknown route in the right deltoid on 01-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; and POLIO VACCINE (POLIO VACCINE).  It was an actual medication error due to expired vaccine used. It was reported that the reporter noted that the first vaccine had been expired when it was given.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patient was seen today for an immunization visit with nurse. Initially, patient was due for 5 vaccines, but was only given 2 vaccines. The vaccines given was Hep B and MMR was administered after. After patient was given second vaccine, MMR, patient had a suspected adverse reaction to vaccine. Patient's body went limp and fell head first on to a chair before falling to the ground and hitting his head. Patient was put on his side by 2 staff nurses and seizure-like symptoms began. Patient lost consciousness and his body started to jerk. Episode lasted about 5 seconds. Ambulance was called at this time. Patient was able to regain consciousness and was oriented x3. Patient was able to talk to staff. He denies having history of seizures in the past. He said this has not happened to him before. Patient was able to walk to exam room and sit in chair. After sitting, patient had a second episode of unconsciousness and had same seizure-like movements that lasted about 5 seconds. Patient was able to regain consciousness once again and was oriented x3. Patient was laid on the floor for safety precaution in case another episode occurred. Patient laid down and verbalized he felt fine. Vitals were taken at this time. Blood pressure was 104/56, pulse was 58, and O2 saturation was 100%. Ambulance came around 12:15 pm but patient was still unsteady off his feet.
developed shingles 2 and 1/2 days after 1st Vaccine, went to banner urgent care on 4/23 because of rash starting on 4/19 and was on left torso from belly button to spine left . started as small red bumps and progressed  to. nerve pain /pressure all over left torso. diagnosed on 4/23 at as shingles. took anti viral for 7 days . (VAL?)
This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Extremely large lymphadenitis in left axillary region and left supraclavicular area following fever, chills and body aches. Left accolade swelling the size of grapefruit with pain and tenderness. Left supraclavicular area tender to touch and warm also.
This is a spontaneous case initially received from the pharmacist on 08-Nov-2018, concerning a 60-year-old, adult female patient. On 03-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019). On the same day after the vaccination, the patient experienced rash in the middle of her face in the nose area which was radiating from the nose in the shape of a butterfly, one to two inches. The patient's husband noticed it immediately after the shot. The patient did not receive any treatment measure associated with the event. At the time of this report, the patient had not recovered from the event (reported as ongoing). The reporter assessed the case as non-serious.
Patient reported left arm numbness and tingling after one month. EMG ordered, awaiting results;
vaccine date 8/28/21- pt went into labor 2 weeks early on 8/31/2021, pt had myocardial infarction due to coronary artery dissection on 9/17/2021
pt recv vax 29MAR97 & 31DEC97 pt devel shingles, face & cheek;pt devel 10 on face & a couple on throat;it was hared to identify the # of lesions because they were all gunked together into one lesion;pt exp to sibling who devel chickenpox;
The expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Received COVID moderna vaccine on 01/22/21 and 02/22/21. No booster. Presented to ER on 12/2021. Presented to the hospital secondary to hypoxia and shortness of breath from COVID-19.  Was diagnosed with COVID pneumonia.  She was placed on dexamethasone and remdesivir.  With the IMC on oxygen per protocol.  Also was found to have UTI for Klebsiella pneumoniae.  She is on azithromycin and ceftriaxone.  Was on high-flow oxygen for several days titrated back eventually to oxygen via nasal cannula.  Blood pressure medications were held as she was normotensive.  Electrolytes were followed and replaced as needed.  Was noted to be anemic but without acute bleeding and transfused with 1 unit of packed red blood cells and her hemoglobin remained stable thereafter.  Physical therapy and occupational therapy saw this patient for safe mobilization.  Completed her course of remdesivir.  Completed antibiotics courses on 12/26/2021.  Clinically and via x-ray there was significant improvement in her COVID pneumonia.  Was transferred to regular floor on 01/03/2000 22. Underwent 6 minute oxygen walk on 01/05/2022 and was not needing supplemental oxygen.  She was at her baseline in declined home health care.  Was discharged home with plans for close follow-up on 01/05/2022.  Had been on Lovenox throughout her hospital stay at 40 mg b.i.d. secondary to weight. Discharged on 1/5/22
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2, single (Lot number: Fh8028) at the age of 27 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 Weeks was No. Patient reported that she had no known allergies. The patient received anti-viral COVID 19 Treatment from 30Jun2022 to 04Jul2022.
Pt c/o sore arm developing on Friday following vaccine. Saturday experiencing diarrhea, muscle pain and chest discomfort. Monday following vaccine advised to do a covid test. Contacted nurse Tuesday and having left sided chest discomfort with movement and taking deep breaths. Appt for follow up booked on Wednesday and pt advised if chest pain worsens, becomes sob, pain radiates to arm/jaw must follow up at nearest ED.
Headache, Myalgia, Fever, NauseaVomiting, Tachycardia, chills Narrative: