chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tightness in her throat; shortness of breath; her right arm was aching and went up into her shoulder and neck; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration in the left arm on 01Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history included food allergy allergies to soy, drug hypersensitivity, allergies to antibiotics, drug hypersensitivity from an unknown date and unknown if ongoing allergies to blood pressure medications and the patient had lung problems, she does not have COPD, but she has bacteria in her lungs called MRSA. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tightness in her throat, shortness of breath, her right arm was aching and went up into her shoulder and neck. She checked her oxygen levels, and they were fine, so she did not go to the emergency room. The patient was due for her second dose next Monday. Therapeutic measures were taken as a result of tightness in her throat, shortness of breath, her right arm was aching and went up into her shoulder and neck. The patient took a breathing treatment and it helped some and had Benadryl and had going into deep sleeps at times. The outcome of the events was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to an 18 month old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 17-AUG-2015, the 18 month old patient was vaccinated with a dose of GARDASIL injection (strength, dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse experience was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over  Sweated all night  Swollen armpit lymph node Headache
Presented with SOB, normally on NC at night, hypoxic on RA. Required O2. Dx with COVID PNA, received Remdesivir and steroids. Patient does not remember receiving vaccine. Discharged to inpatient hospice and later expired.
Red,swollen warm touch left arm 2/17/09 0600   treatment was given on 2/18/09 at 01000 Benadryl 12.5mg/5ml and Cleocin 75mg/5ml
Itching, swelling, redness at site; rash down arms; throat tightness and difficulty swallowing w/ change in phonation of voice.
Narrative:  Patient states he received 2 vaccines on 4/19, PPV23 on right arm and Herpes Zoster on the left here at clinic (documented). Patient states he woke up this morning and his right arm was red and painful. Patient states he has not taken anything for it or tried to treat the area with anything. Right arm- Redness and swelling noted from upper arm/shoulder to elbow. No heat, drainage, streaking, hives, open areas of skin noted. New script for Benadryl given for fill at pharmacy.
Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VARIVAX (Oka/Merck). On 09-APR-2008 the patient had shingles. Unspecified medical attention was sought, at the doctor's office. There was no product quality complaint. Additional information has been requested.
51 y.o. male from Facility.  The patient was seen at his primary care physician's office for some left facial swelling.  Apparently, he started getting more short of breath while he was there.  He was sent in by EMS.  His sats were initially in the upper 80s at his primary care physician's office.  He denies any symptoms of URI, but does state he has a long history of COPD.  The patient was given some DuoNebs and supplemental oxygen in the emergency room and shortness of breath basically resolved.  However, he did have very significant left facial swelling.  His CT did show facial cellulitis with possible abscess, but no fluid collection.  His white blood cell count was almost 25.  He had been having fevers at home.  Because of all this the decision was made to admit for IV antibiotics.   When I saw the patient, he was willing to stay for IV antibiotics for a few days.  3/11/21 remains hospitalized
Mild pain at injection site Mild fever   Moderate Chills Severe joint pain Mild fatigue
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) Lot number K009756 and expiration date: 09-JUL-DEC-2014 (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
I noticed I had leg pains and effected my walking. It eventually effected my knees and hips. I was vaccinated in May 2021, the pain started in late Aug.-Sept. 2021. I also experienced extended pain in my arm where I received the injection.  It felt like extreme growing pains in my legs, Like it was going into overdrive with the aches. When I felt the pain in my legs, I would sometimes feel the pain in the arm where I received the injection.
Case number PHEH2014US022099, is an initial spontaneous report from a medical assistant received on 03 NOV 2014. This report refers to a 14 months old male infant. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 145303) intramuscularly on 27 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Swelling and discomfort of lymph node in neck on left side (same side as vaccine administration) starting 2 days after dose. Patient chose to monitor at home and not seek medical attention. Has gradually reduced and as of 11/24/22 was almost back to baseline.
REDNESS, SWELLING AND PAIN AT INJECTION SITE MEASURING 1 1/2" BY 2 1/4"
Administered 0.5mL instead of 0.25 mL for booster dose.
lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included borderline hypertension and allergies to latex. Patient was not pregnant. Concomitant medications included atorvastatin, lisinopril, and fish oil. The patient previously took morphine and had allergy. Patient reported that the day after the vaccination, she experienced lightheaded, tired, and achy at 2pm on 23Jan2021. She had these symptoms every day since. Some days it happens more often than others.  It happens at different times such as lying down, walking, etc. No treatment was given. Outcome of the events was not recovered.  Information regarding the lot/batch number has been requested.
3/18/21: Vaccine Administered 3/20/21: Begin running a low-grade fever (99.6-100.4) and general lethargy 3/22/21: Wake up with searing headache, severe chills, lethargy, and high fever (peaking at 101.8) 3/23/21: Moderate headache, high fever remains 3/24/21: Gastrointestinal problems (diarrhea, nausea); moderate fever remains 3/25/21: Sore throat develops; moderate fever remains  3/26/21: Fever begins to subside, mild headache, mild sore throat 3/27/21: Three days of loss of appetite; no significant fever
Information has been received from a medical assistant referring to a 41 year old male patient who had no pertinent medical history or drug reactions/allergies. On 29-JUL-2013, 26-AUG-2013 and 24-FEB-2014, the patient was separately vaccinated with a dose of RECOMBIVAX HB (strength:2.5/0.5, dose: 1.0 ml), (lot# separately reported as 190AA with expiration date 11-MAR-2013, 148AB with expiration date 06-SEP-204 and 209AB with expiration date 07-MAR-2015), intramuscularly. The patient had no concomitant medication. On 12-JAN-2015, hepatitis B titer was drawn and the result was below3.1. The patient had a low hepatitis B titer (hepatitis b surface antibody negative). The patient did not seek medical attention. There was no treatment given to the patient. The outcome and causality of the event was not reported. Additional information has been requested.
On August 11, 2022, I tested positive for COVID-19. I had a really bad head cold. I contacted my doctor and was prescribe Paxlovid for five days.
FELT LIKE HE WAS GOING TO VAGUL, GOT VERY LIGHTHEADED AND SWEATING
Patient is a 64 y.o. female patient with history of small cell lung, CAD status post MI, COPD presented to Medical Center with worsening hypoxic respiratory failure, sepsis, CAP and found to have COVID-19 infection as well.    Acute respiratory failure with hypoxia CAP + COVID treatment as below CT PA study on admission did not show any major PE however concern for mucus plugging/possible aspiration. MBS without aspiration. Required 5L NC initially, later went on HHFNC. CT PA study repeated for increased O2 requirement on 4/24, no PE noted.   Weaned off HHFNC to 4L NC on 4/26. Hypoxic event during her afternoon Radiation Therapy on 4/28, coughing fit lying flat - RT was aborted. O2 requirement increased significantly, back on HHFNC. Continues to require HHFNC, worsening status again on 5/10 AM and placed on BIPAP. CXR repeated on 5/10, with severe emphysema. Back on HHFNC now, 75% and 70L.  BLE venous duplex ordered per Pulm and negative, as discussed with them ordered V/Q scan. Prolonged steroid taper completed, continue diuresis as tolerated.  Discharge to LTAC in progress.    Sepsis, POA- resolved Presumed right-sided community-acquired pneumonia POA CT PA with extensive R side pneumonia, mucous plugging, severe emphysema Blood cx negative to date MRSA, Strep pneumo negative, SCx normal flora after 48 hours Rocephin/azithromycin completed.   COVID-19 Date of onset of symptoms: 4/8 Symptoms present on admission: Cough, dyspnea, weakness Date of covid positive test: 4/11/23 Vaccination status: vaccinated x2 and boosted x1 Imaging: CTPA as above Oxygen requirements on admission: 5L Current oxygen requirements: HHF with bipap, 50%, 60L. Medical therapy: Completed course with remdesivir and steroids Consultants following: Pulm Special isolation end date: 4/22   COPD with acute exacerbation Completed steroid taper on 5/13. Resume home inhalers, nebulization. Small cell lung cancer Currently undergoing radiation treatments Follows with Dr. Rad onc follows and underwent sessions while here, unable to tolerate last session on 4/28. Oncology consulted.    Hyponatremia, resolved Euvolemic, probably SIADH component due to lung disease Na 127 on admission and normalized;  Held free water flushes through PEG tube, diuresis started.  Na improved now.    Esophageal ulceration; suspected candidal infection Dysphagia  Severe malnutrition, POA Due to radiation G tube placed week PTA.  Dietician consulted for TF assistance. S/p completion of Diflucan on 4/20 for suspected candidal esophagitis-no biopsy results in the chart SLP consulted -- initially with ground meats, thin liquids and later advanced. MBS (4/25) without evidence of aspiration.    CAD Denies chest pain. Home ASA, atorvastatin, metoprolol resumed.    Goals of care Changed to DNR-CCA but  OK with intubation on 4/12, later changed to DNI as well.  Wants daughter to be HCPOA Palliative care consulted & follow.    Anxiety Uncontrolled and worsening respiratory status. IV Ativan PRN and Atarax
Chills; body aches; Body aches made movement difficult; Temp not taken but felt like had fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; PAIN (non-serious), outcome "recovered", described as "body aches"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Body aches made movement difficult"; PYREXIA (non-serious), outcome "unknown", described as "Temp not taken but felt like had fever". Additional information: The events chills and body aches started hours after 2nd shot given at 10 am and began to resolve by 10 am the next morning. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 10-month-old female who on 14-SEP-2006, 17-NOV-2006 and 22-JAN-2007 was vaccinated PO with the first (Lot #654422/0607F), second (Lot #654663/0942F) and third (Lot #655406/1114F) doses, respectively, of Rotateq. The nurse reported that on 17-MAY-2007, the patient was admitted to the hospital and tested positive for rotavirus. The patient was treated with hydration therapy. At the time of this report, the outcome was unknown. Additional information has been requested.
Day after vaccination, pneumonia injection site, very sore developed red line around site to post chest call.  Stated "it even hurt to lift up my arm".
Reaction: sharp chest pain  Treatment: Patient advised to go to ER, patient left AMA.  Outcomes: Didn't seek medical care because pain diminished. Reported feeling fatigued for a couple days after receiving the vaccine, but doing well other wise.
Moderate pain to touch at right shoulder capsule (not injection site);  moderate pain in same area on full extension  of  right arm.  Pain to touch was stronger for first week after onset but condition has remained constant.  This is not pain at the right arm injection site which was normal tenderness for 24-48 hours.  The reported reaction was in a different location (see above) and was not noticed for several days after injection.  Shoulder has no known structural problems or chronic pain. Condition is not resolving.
Difficult breathing/chest pain; Difficult breathing/chest pain; severe headache; muscle pain all over body; injection site swelling; weakness throughout the body; was bedridden for 24hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 09Sep2021 02:00 (Lot number: 301358A) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing), notes: known_allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "Difficult breathing/chest pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe headache"; MYALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "muscle pain all over body"; VACCINATION SITE SWELLING (non-serious) with onset 10Sep2021, outcome "not recovered", described as "injection site swelling"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "weakness throughout the body"; BEDRIDDEN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "was bedridden for 24hrs". Therapeutic measures were not taken as a result of dyspnoea, chest pain, headache, myalgia, vaccination site swelling, asthenia, bedridden.  Additional information: Facility where the most recent COVID-19 vaccine was administered was noted as military base. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Developed dizziness.  Had several episodes a week or so after the shot getting progressively worse.  On April 10, 2021 three bad episodes - last one resulted in fainting and splitting head open.  EMT's came took me to the hospital and on April 12th I had a pacemaker installed.  Breathing problems improved after pacemaker.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.
Patient presented with red, itchy rash that is warm to the touch. It is located approximately 4 to 5 inches below injection site (just above elbow). Patient presented a few days after vaccine administration.  Patient stated she was going to have it looked at by medical professional. Pharmacist recommended Benadryl and icing the area.
My almost 10 month old son received Hepatitis A vaccine. Before the vaccine I asked the nurse which vaccine she recommends that the baby receive this visit to catch him up to his vaccine schedule. She also recommended that I receive PCV 13. The nurse told me that she spoke to the triage nurse and that the triage nurse recommends getting Hepatitis A due to our travel international later this month. This morning the triage nurse said that she reviewed the charts and noticed that our baby received the hepatitis vaccine prematurely. She apologized and said that the nurse was not in that day and has yet to speak to her. The triage nurse told me that the error was given 8 weeks prematurely and should not be given to children under 1 year old.
he can´t move his arm; arm pain; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who arm pain/pain in extremity and couldn't move his arm/injection site movement impairment.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  Beginning on 01FEB2021, the patient began experiencing arm pain and that he couldn't move his arm.    Treatment of these events were not reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, pain in extremity and injection site movement impairment were considered unknown.
PATIENT REPORTED THAT SHE IS STILL HAVING A SORE ARM/JOINT/SHOULDER PAIN 1 MONTH AFTER SHE RECEIVED HER VACCINE. THE PHARMACIST GAVE HER A BOTTLE OF APAP AND NAPROXEN.
Patient experienced cough, nausea and vomiting severe enough to cause patient to seek medical attention at a hospital.
On day 1-day of vaccine patient had chills, fever of 102, and elevated B/P of 200/160. Day 2-Lymph nodes became swollen, tender and sore-especially under both arms, patient had dizziness and nausea. Day 3-Lymph nodes remain swollen, tender and sore under both arms, and nausea.
17 pt's were vax w/2 doses of varicella vax & lab eval 6-7wk post vax revealed 11 neg titers & 6 equivocal titers;
Next day after vaccine. Weakness and fatigue and confusion, back pain and low grade fever, malaise, lethargy. After vaccine, slight wheeze within 10 minutes of Hep B injection.
fluid around the heart/inflammation; patient had a bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around the heart/inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PERICARDIAL EFFUSION (fluid around the heart/inflammation) (seriousness criterion medically significant) and IMMUNISATION REACTION (patient had a bad reaction). At the time of the report, PERICARDIAL EFFUSION (fluid around the heart/inflammation) and IMMUNISATION REACTION (patient had a bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment drug was provided by reporter.  Company comment: This spontaneous case concerns a unspecified age female patient, with no medical history reported, who experienced unexpected serious (medically significant) of pericardial effusion, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. At the time of reporting outcome of event is unknown. No further details about clinical course, lab test, treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female patient, with no medical history reported, who experienced unexpected serious (medically significant) of pericardial effusion, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. At the time of reporting outcome of event is unknown. No further details about clinical course, lab test, treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a health care professional concerning an 8 month old female who in May, 1989 was vaccinated with 1 dose of MMR and on 5/12/1989, the pt experienced a screaming reaction and a measles-like rash. The pt was taken to an ER for evaluation. No further information in available.
On 06/23/2022 I had a sore throat then several hours later I started to have a fever. I contacted my doctor and was prescribed a five day course of Paxlovid.  Within 48 hours I noticed my symptoms were getting better.  I still have a lingering feeling of needing to clear my throat a lot and some coughing attacks.
10 minutes after shot I got very hot and tingly and felt out of sorts for 5 minutes,do have history with anaphylactic shock during chemo infusions 10 years ago
This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Pregnancy and Lupus erythematosus.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The patient received two primary series mRNA-1273 vaccine COVID-19 vaccines. The patient had recently seen her doctor who advised the patient to receive "third mRNA-1273 Vaccine".