chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6/24/21 I was taken to A Medical Center, after going to my cardiologist, with extremely low heart rate.  I was paced.  No one has an explanation for the adverse effect on my heart.  I was doing  fine until I had my 2nd
Immediate pain at injection site upon needle insertion. Injected 0.5mL Moderna COVID vaccine in R Deltoid. Injection location looked slightly low, slightly mid-medial, however within appropriate injection area. No bleeding or bruising at time of injection. Advised to take APAP tonight and come back tomorrow if pain concerning, or go see doctor if signs of infection or nerve damage. Came back 4/30 concerned about shoulder, c/o 9-9.5/10 pain, though was not crying or limited in everyday activities other than sleeping. Deltoid felt slightly firm to touch, maybe a tad bit warmer than other shoulder, very minor bruise at injection site. No shooting pain down arm, no lack in range of motion (very slight increase in pain when moving arm towards back). No signs of fever or infection - just seemed like typical immunization reaction localized at injection site. I was apologetic that she was in pain, advised to use ice on top of using APAP and IBU, reassured that she should get better over the weekend, contact medical help if pain worsens, signs of infection arise, or range of motion becomes limited. I attempted to reach out 5/3 but had to leave a voicemail.
pt recv vax 6AUG96 & 24OCT97 pt exp a mild atypical case of chickenpox w/approx 15 to 20 lesion;
stomach aches; wet cough; her arm was hot at the injection site; This spontaneous report was received from a patients daughter who was referring to her 84-year-old mother- female patient. Her concomitant therapies included vitamin d (unspecified) and naproxen sodium (ALEVE) taken as needed (prn). It was reported that the patient could not get the COVID-19 vaccine due to shellfish and iodine allergy, therefore a physician prescribed pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) .   On 23-FEB-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injected in arm (exact dose, frequency, lot #, expiration date and route of administration were not reported) for elderly and to prevent pneumonia.   On the same day, she experienced a reaction after administration of the vaccine, her arm was hot at the injection site and she experienced stomach aches and wet cough. The patient sought medical attention and spoke to a physician. Benzonatate was prescribed for cough. The patient stated that the stomach aches still occurred in the evening when vitamin d (unspecified) was taken. She inquired if there were any interactions between vitamin d (unspecified) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and asked about ingredients in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The outcome of the events was reported as recovering. She still had slight cough. The causality assessment was not provided.
Mother called on 8/29/03 stating child had broke out with "two dozen" lesions but was afebrile and voiced no other complaints. MD visit on 9/2/03 due to febrile state and increase in number lesions.
A pediatric Pfizer dose was given instead of a Pfizer booster dose.  Repeated dose with proper formulation per CDC guidelines.
Pt recv vax on 4/6/99; 45 min post vax pt exp rash, itching, puffy cheeks, red/ raised/ itchy rash on body; tx=Benadryl
Received MMR on 9/26/2006.  Symptoms began one week ago.  During the past week, client has had 3 different episodes of chilling; also has had chest pain with in the past week, this was described as a dull ache with occasional sharp pain.  During this time, she has also complained of anterior and posterior back and lung pain.  During the past week, she has also noted some behavioral changes.  She described these changes as being agitated, along with being irritated to the point of paranoia.  She states she has had a heightened sense of awareness, has been overly irritated by things that should not have bothered her, and also complained of nervousness.  Within the past two days, she states she has had a headache and an overall sense of ill feeling.  On October 10, she states she developed symptoms of weakness, dizziness, and difficulty breathing.  The difficulty breathing and chest discomfort has continued throughout the day today, and she states she is slow, lethargic, and has to consciously form her words. Her temperature today was 98.7F.   Due to described symptoms of chest pain and difficulty breathing, was instructed to seek medical care.
stiff neck next day, progressing to fever, chills, gen myalgia/arthralgia, hives, sores, weakness, fatigue, abnormal liver function;cont very weak;
High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches continue Ibuprofen and Acetamenophen to reduce fever.
pt recv vax & devel 2cm spot & soreness for a few days afterwares;whole upper arm hurt for 3 dasy, upset stomach, diarrhea a day p/the 2nd dose, by the forth day pt was fine;
severe joint pain, chills, nausea, vomiting, swollen lymph nodes above clavicle
Mother called office on 3/6/19 with report of temp 103. Nurse call on 3/8/19 reveals no further temps, doing well.
Headache for three weeks. Severe joint pain i.e. shoulders, knee. Fatigue as of 6 Sep 08. Stomach nausea. Per follow-up: Joint pain, headaches lasting for days, fatigue, sweating.
Injection site pain; Chills; Fever; Heart racing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 from 17Jan2021 to an unknown date she reports that she had the Covid virus on 17Jan2021, before the Covid vaccine, and her heart rate was up to 132 beats per minute. The patient's concomitant medications were not reported.  The patient experienced injection site pain, chills, fever on an unspecified date with outcome of unknown, 15 minutes to an hour after the vaccine she had her heart racing she didn't notice it until last night which is usually high, around 80 to 90 beats per minute anyway on an unspecified date. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, heart rate: 132/min 132 beats on 17Jan2021, 80 to 90 beats per minute on an unspecified date.. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "Well control type 2 diabetes" (unspecified if ongoing); "slightly elevated blood pressure" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2009. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on treatment with Paxlovid from 31Aug2023 to 05Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298972 same patient, different drug/event (Paxlovid case);
shingles rash on back and on left arm and hand treated with 7 day antiviral and gabapenton for pain still ongoing
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates the patients were administered improperly stored oral, ROTATEQ (lot # L013192, expiration date 19-JAN-2017) (dosage and strength unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tiredness. Fever (100.7). Muscle ache. Joint ache. Headache. Injection site redness, mild swelling and discomfort.
lit ref:p/recv vax pt devel fever 104F, jaundice, hepatosplenomegaly, elevated liver function; Dx=neonatal hemochromatosis; awaiting liver transplant; devel Klebsiella pneumonia, septicemia & hypotens; Dx= hemophagocytic lymphohistiocytosis
Breakthrough COVID Case: I had a lot of weakness and was coughing. I also had headaches a day or so later. I felt like I had a sinus infection. I was bringing up sputum that was thick and yellow. My eyes were red and I had night sweats. I sort of lost my appetite.
Information has been received from a nurse practitioner concerning a 23 year old female patient with no drug allergies or pertinent medical history who on 10-MAY-2010 was vaccinated with the first dose of GARDASIL (Lot number 663454/0672Y, expiration date 19-SEP-2011) IM. There was no concomitant medication. The nurse reported that in the evening of 10-MAY-2010 the patient developed stomach cramping, diarrhea, fever of 100.5 degrees F and chills. The patient was seen in the emergency room and was told it was a viral infection. The patient was given BENTYL and was told to take ibuprofen for the fever. On an unspecified date the patient recovered.  Additional information has been requested.
C/o (R) arm and body tenderness, malaise starting approx 12-16 hrs post vaccination.
trouble breathing; short breaths; couldn't breath well; throwed up; bones hurt; chills; super shaky; really sweating; really sick; sore arm; tired; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing) and RESPIRATORY RATE DECREASED (short breaths) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (really sick), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating). At the time of the report, ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative:.     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.   Reporter did not allow further contact
This spontaneous report was received from a physician via a sales representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of GARDASIL (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient fainted after receiving the dose of GARDASIL. No treatment information was reported. The outcome of fainted was unknown. The relatedness for fainted was unknown for GARDASIL. Additional information is not expected.
Information has been received from a 60 year old female pharmacist via a company representative referring to the pharmacist herself. The patient's concurrent conditions, medical history and concomitant therapies were unknown. On 15-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # and dose unknown, subcutaneous). On approximately 17-JUL-2016 (reported as about "2 or 3 days later"), the patient developed an "itchy raised rash" about the size of "2 half dollars" around the injection site. She treated the rash with cold compresses and also took ibuprofen for minor pain (onset date unspecified, approximately in July 2016). The patient also reported the rash and itchiness all went away 2 days later (approximately on 19-JUL-2016). No labs performed for the events. It was reported that the patient did not seek medical attention for the events. The outcome of pain was not reported. The causality was not reported. Additional information has been requested.
11 mo with Wolf-Hirschhorn syndrome had PREVNAR on 11/15. Went to ED in Status epilepticus. Required an IO to be placed. Transferred to ICU on 11/16.
mom called clinic stated pt was fine last noc but this morning pt is running low grade temp w/rash from ankles to head;instruct mom to see PMD ASAP called later pt better, rash diminishing, did not see PMD;
3 days after receiving ZOSTAVAX, patient had a 5 inch area that was red, raised, and warm across the back of her arm.
felt horrible; lost her balance; blood pressure rose; frozen legs; legs felt stiff; extreme Fatigue; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure rose), MALAISE (did not feel well), SENSORY DISTURBANCE (frozen legs), FEELING ABNORMAL (felt horrible) and BALANCE DISORDER (lost her balance) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myeloma (Not relevant to vaccine.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (did not feel well). On 28-Feb-2021, the patient experienced SENSORY DISTURBANCE (frozen legs), MUSCULOSKELETAL STIFFNESS (legs felt stiff) and FATIGUE (extreme Fatigue). On 06-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure rose). On an unknown date, the patient experienced FEELING ABNORMAL (felt horrible) and BALANCE DISORDER (lost her balance). The patient was treated with AMLODIPINE BESILATE (NORVASC) at an unspecified dose and frequency and CLONIDINE at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (blood pressure rose), MALAISE (did not feel well), SENSORY DISTURBANCE (frozen legs), FEELING ABNORMAL (felt horrible), BALANCE DISORDER (lost her balance), MUSCULOSKELETAL STIFFNESS (legs felt stiff) and FATIGUE (extreme Fatigue) outcome was unknown.            Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Second follow up received and she was diagnosed with myeloma.
WHILE WAITING PATIENT LOST CONCIOUSNESS AND WAS REGAINED WHEN SHAKEN. PATIENT WAS SWEATY AND REPORTED THAT SHE FELT THAT SHE NEEDED TO LAY DOWN AND NAUSEAUS. WHEN PAREMDIC ASSESSED HER, HER HEARTRATE, BLOOD PRESSURE AND BREATHING RATE WAS NORMAL. HER BLOOD SUGAR WAS ELEVATED AT 146.  AFTER 30 MINUTES  OF DRINKING WATER AND EATING A NUTRIGRAIN BAR PATIENT BECAME FULLY ALERT AND WAS ABLE TO STAND/WALK UNASSISSTED
Heart attack;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4241744-00 (AbbVie).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3, (booster) single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen subcutaneous since Sep2021 (Batch/Lot number: unknown) and second regimen since 07Jan2022 (ongoing) (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Hospitalized", start date: Mar2021 (unspecified if ongoing); "Confusion" (unspecified if ongoing); "Did not feel right" (unspecified if ongoing); "Cellulitis", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Intra-muscular), administration date: Feb2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Cellulitis"; Bnt162b2 (Dose 2, Intra-muscular), administration date: Feb2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Cellulitis". The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "Heart attack". The patient was hospitalized for myocardial infarction (start date: 10Jan2022, discharge date: 11Jan2022, hospitalization duration: 1 day(s)). The action taken for risankizumab was dosage not changed.  Reporter's causality for Skyrizi for the event(s) of heart attack was not provided and reporter causality for pfizer biontech COVID-19 for the event(s) of heart attack was possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between all the reported  event myocardial infarction and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine three months ago and a few days later developed shingles.  The shingles had resolved, and he received his second dose the date before reporting. The reporter did not consent to follow up. MD follow up call declined provided information regarding shingles and Shingrix per FAQ.
arm red, sore, 3" x 2 3/4" daim burning, pain between shoulder & elbow; large round burn look, hot to touch
Strain in left arm and left side of neck shortly after injection requiring physical therapy and the strain has still not fully healed after extensive physical therapy. I have an appointment with an orthopedic specialist scheduled.  Not 100 percent sure the strain is directly related to the vaccination but the strain is in the area of the vaccine and the strain occurred very shortly after the vaccine. Seems not a coincidence.
Patient tested + for covid on 1-21-2022.    deceased on 8-18-22.   Had metastatic colon cancer , passed away at home.  Not recently admitted to the hospital and last admit there was 4-2021 with anemia.
received 1st dose years ago, not sure if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023  Reporter's comment: The pharmacist stated that she was not sure if the patient may had received the 2nd dose elsewhere but could not find it documented in the database. The reporter stated that she was getting this question more.  The reporter did not report any other patients who was late with the 2nd dose. The reporter did not know the exact date of the first dose. The reporter consented to follow-up via postal. The case was linked with case US2023AMR014484, reported by same reporter for different patients. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023AMR014484:same reporter
This spontaneous report as received from a healthcare worker refers to a 22 year old male adult patient. on 21-JUN-2013 ("today") the patient was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 670709/0820AA, expire date 02-JUN-2013), Injection that has been expired. No adverse effects reported at this time. Additional information is not expected.