chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Concomitant therapy included influenza virus vaccine (name and manufacturer unknown). Lot# was not provided. The patient developed hives after getting GARDASIL and influenza virus vaccine together. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Symptoms started on 8-16-07. Pt c/o sore arm, inability to have complete ROM. Fever 101 and HA. Pt was advised to rest arm and use Ibuprofen for fever.
After small pox vaccine, erythema, scaly, fissuring of palms/soles of feet for 11 months not resolving.
Information has been received from a RN concerning a 20 year old adult white female with no known drug allergies who on 03Jan03 and 10Feb03 was vaccinated SC in the left arm with the first and second doses of varicella virus vaccine live. There was no known illness at the time of vaccination. Concomitant therapy that day included a dose of (ENGERIX B) administered IM in the right deltoid. No further information is expected.
pt recvd vax 8SEP95 & 1wk later devel a localized inj site rash consisting of bumps;f/u the nurse indicated that pt's sx were felt to be viral & not related to varicella vax;
Heavy bleeding and inflammation where IUD was; Heavy bleeding and inflammation where IUD was; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included intrauterine contraceptive device (PARAGARD) taken as contraceptive, start and stop date were not reported. The patient experienced heavy bleeding and inflammation where IUD was on an unspecified date .  She had her Paraguard IUD removed on an unknown date.Outcome of the events was unknown.
2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired; 2nd dose were a little stronger in that she was more achy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) from 13-May-2021 to an unknown date for Rheumatoid arthritis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 experienced FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy). At the time of the report, FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy) outcome was unknown.            No treatment details reported.   This case was linked to MOD-2021-381984, MOD-2021-382082 (Patient Link).
Headache, Myalgia, fatigue Narrative:  Headache, myalgia, fatigue.
Difficulty breathing, loopy, confused, fainted, chest pain going into my arm and jaw, nausea.
90 y.o. male with a past medical history of dementia, CKD 3 with anemia, hypertension, hypothyroidism, hyperlipidemia, MVP, prostate cancer, ulcerative colitis, CAD status post stents in 2015, PAD, osteoporosis, abdominal aortic aneurysm who presents nausea and vomiting as well shortness of breath.  Patient admitted as observation on 5/19 due to acute respiratory failure with hypoxia due to COVID.
Pt complained of left leg redness and swelling of thigh area. No pain and not warm to the touch. Pts advised to treat with Children's Motrin and apply ice to affected area. Also advised to seek medical attention if symptoms worsen.
occasional pain radiating from my heart down my left arm; occasional pain radiating from my heart down my left arm; tightness in my heart and all around my heart; a lot of fatigue; difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EWO173), via an unspecified route of administration, administered in left arm on 16Aug2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization. Medical history included BPES syndrome from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not pregnant, was not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks prior. Concomitant medications included vitamin C, garlic, lysine, calcium, and multivitamins, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro, metronidazole, tetracycline and Macrobid, and experienced allergies. On 16Aug2021, the patient felt like she had tightness in her heart and all around her heart, occasional pain radiating from her heart down her left arm, and also had a lot of fatigue and difficulty concentrating. This had been happening since she received the vaccine. No treatment was received for the events. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
I noticed my Lymph node were swollen on left side. By Monday they were better. On January 07th, I was leaning over edge of bath tub bathing my grandchild and all the muscles in my back ceased up. I had to have someone come pick me up off the floor. I had 1 similar experience a  long time ago but I don't recall the circumstances surrounding this event. Afterwards I called the doctor and was prescribed muscle relaxer. I still have as little twinge from this every now and then. If I sit still too long, its hard to get up.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    Concomitant product use was not provided by the reporter.  lot 939902 reported with a BUD of 02-Sep-2021.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received included non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Several weeks post vaccine L shoulder pain inject. site. Spread to shoulder upper arm (pain). Restricted shoulder movement/increased pain. Primary care Dr. sent me to PT, MRI, surgeon; diagnosed adhesive capsulitis. Surgery 6/5/12. PT 6/13-9/13. Improved, still pain with some shoulder restriction. PT says several women in for therapy after flu vaccine. Same vaccine 2011: exercises per primary care dr - most pain gone, most restriction gone by 2/12. Advised no flu shot arm.
CANCER; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cancer. It was reported that "My boyfriend and best friend, both developed 2 different cancers after receiving the shot. Weird, Coincidence. Or is the shot what some say it is. It sure wasn't tested long after it was made". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221146108.; Sender's Comments: V0:20221143605-Cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
From initial information received on 11/24/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received a dose of Menomune A/C/Y/W-135, lot number UB487AA, administered subcutaneously in her left arm on 10/23/2003. One hour after receiving the vaccine, the patient complained of abdominal pain. She was seen by a physician and a chemistry screen and complete blood count were normal. Reportedly, the patient recovered from this event. From additional information received on 02/23/04 form the initial reporter, the case was reviewed and no additional information is available at this time. No further information is anticipated, this case is considered closed.
nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Cholesterol. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatmment Information was not reported.  Concomitant medications included unspecified cholesterol medication and unspecified hypertension medication.
Pt was receiving warfarin therapy, given vax during week of Oct 5, 1997. Oct 13, Pt's prothrombin time was found to be elevated
SOB, lightheaded, chilled, myalgia, and nausea. 24 hours later-better.
Bell's Palsy; This is a spontaneous report from a contactable physician. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date in 2021 (reported as a month before this report) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021 (reported as a month before this report), the patient experienced Bell's palsy. Outcome was unknown. The reporting physician was asking if the second dose is required. Information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association, a reasonable possibility that the reported Bell's palsy is related to BNT162B2 vaccine 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.
pt recv vax then woke up from nap 6 hr later fussy, crying gasping- turned pale then blue while episode lasted 5-6mins;paramedics called temp was warm;
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA344670, 2018SA344695, 2018SA344665, and 2018SA344687 same reporter. This case involves a 67 years old female patient who received vaccine FLUZONE HIGH DOSE lot UHJ006AA, expiry date: 14-APR-2019 via unknown route in the left deltoid on 06-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event was occurred. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
COUGH, Fatigue, Muscle or body aches, Headaches and Congestion or runny nose
This is a very pleasant and healthy 21-year-old with history of migraines with aura who presents to the ER 2 days after receiving his second Materna vaccine with complaint of chest pain, myalgias and fatigue.  Patient reports normal postvaccination myalgias and fatigue for the last 2 days but had onset of left-sided chest pain that radiates to his upper back and is worse with deep inspiration, some positions and movement of his left upper extremity.  He denies cough, shortness of breath or rash.  He is low risk for pulmonary embolism with PERC score negative for PE.  Screening EKG showed a sinus rhythm with elevated J point in anterior-lateral leads, ? ST elevation in 1 and AVL w questionable reciprocal changes in leads 3 and AVF.  Patient went to CXR.  Clinically very low risk patient for STEMI from CAD.  ? Myocarditis or pericarditis?  No hx of stimulant use or early CAD in family.  Upon reevaluating the patient, clinically he seems to have musculoskeletal chest discomfort, worse with palpation and movement of LUE. Repeated EKG - showed more definative ST elevation through anterior and lateral leads with reciprocal changes in 2, 3, AVF.  Slight ST elevation in AVL.  ? Pericarditis vs myocarditis.     Will call cardiac alert.  Evolving EKG changes.  Discussed with ED physician and Interventional Cardiology, we agreed, patient likely has acute myocarditis clinically.  Very low risk for CAD.  Gave aspirin and heparin.  They will evaluate him.   Labs coming back... wbc 17.4, normal chemistry.  Sending off CRP, ESR.  Troponin pending.   Patient and family appreciative and understanding.   1710 - Follow up call from cardiology.  Stat echo normal wall motion.  With elevated CRP and mild trop 1.6, patient has myocarditis with pericarditis.  Dr very appreciative for the detailed history and physical.  CP free.  Holding off on cath lab.
Headaches; General body ache; Sensation of pressure in the head; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 08:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included clarithromycin (CLARITIN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01G2) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 22:00 the patient experienced headaches, general body ache, sensation of pressure in the head and weakness. Therapeutic measures were taken as a result of the events headaches, general body ache, sensation of pressure in the head and weakness included treatment with tylenol MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events headaches, general body ache, sensation of pressure in the head and weakness was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body aches) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 039A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX, BIOTIN and ASCORBIC ACID (VIT C) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second 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 (chills) and MYALGIA (body aches). At the time of the report, CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406000, MOD-2021-406041 (Patient Link).
Started vomiting at 4:00AM for a few hours, ran a 101.3 temperature and slept all day with no appetite. Mother monitored throughout the day.
I notice a sore neck and my legs were tight in the calf area. I became unable to bend my knees. Sometimes my hips hurt and my muscles in my arms hurt. I have even noticed that my thumbs and toes hurt. This all began in or about August 2022. Now when I try to stand, it takes a moment to get started due to the pain. The pain causes headaches because of the tightness. The pain is like an ache as compared to flu-like body aches. I've done exercises to loosen but this does not help. I have seen a chiropractor, but we have not been able to find a solution. Two weeks ago, when I woke up, I felt very good and was able to kneel down. The next day my pain returned. I have an appointment at the end of April to see a general doctor.
fever, chills, body aches about 14 hours after first dose. Took Tylenol every 6 hours for the next 24 hours.
PATIENT REPORTS SWELLING AND PAIN IN ARM FROM THE INJECTION SITE TO BELOW THE ELBOW STARTING THE DAY AFTER VACCINATIONS
Severe left arm pain and swelling of left armpit the morning following the injection - treatable with over-the-cover pain medication but recurring throughout the day. Fever for the entire day following the injection, peaking at 102.7 degrees but typically hovering around 100-101 degrees. Insomniac episode during the night of the 29th, potentially related to the fever.
Dizziness; Stomach ache; Nausea; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (under several cardiac medications).   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406404 (Patient Link).
2/18/21 itching at site, 2 circles one quarter and one silver dollar size, hot to touch and hard-2/20/21 circles grew to 3 inches and connected-2/22/21 top part of arm faded, turned hot and red/ covid arm- went back to dr. on 2/23/21
Exacerbation of arthritis pain in injection shoulder. Seems to have increased overall joint pain. Missed menstrual cycle - negative pregnancy test.
Breakout case of COVID; 4 days of congestion; 4 days of head cold; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakout case of COVID), NASAL CONGESTION (4 days of congestion) and NASOPHARYNGITIS (4 days of head cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Breakout case of COVID), NASAL CONGESTION (4 days of congestion) and NASOPHARYNGITIS (4 days of head cold). At the time of the report, COVID-19 (Breakout case of COVID), NASAL CONGESTION (4 days of congestion) and NASOPHARYNGITIS (4 days of head cold) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Night of vaccination pt had fever starting at 101 then progressed to 103. She also experienced body aches and sore throat. Symptoms lasted until AM.