chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic lupus erythematosus; Generalized Aching; Muscle pain; This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) in a 58-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) (seriousness criterion medically significant), PAIN (Generalized Aching) and MYALGIA (Muscle pain). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic lupus erythematosus) had not resolved and PAIN (Generalized Aching) and MYALGIA (Muscle pain) was resolving.        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.   On an unknown date,patient experienced lupus.In 2021,the patient experienced body aches and muscle sore.COVID-19 vaccine was also considered as suspect. The patient had lupus.After taking the Moderna vaccine,she experienced a lot of body aches and her muscles were really sore. Daily dose of Humira was citrate free. Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recv vax on 3/3/98; later the same day pt exp injection site rxn of redness,swelling,pain &warmth; pt seen by M.D.;redness was band around arm.  Pt tx=Benadryl &Naprelan.  Pt imp 3/5/98.
Sudden nausea followed with throat swelling which restricted my airway. This lasted for approximately 3-5 minutes. Blood pressure elevated then dropped to 101/53. After a minutes rest in standing BP 99/68. Through out the day experienced fatugued, exhaustion. Around 2:00 PM body began shaking and my heart rate ranged from 103 beats per minute to 117 beats per minute. I was treated in the emergency room for an allergic reaction around 3:00 PM. Heart rate remained elevated ranging from 92-111 bpm through out the evening. I began experiencing back pain while in the Emergency Room and that went away around 4:00 AM the next morning. On 10-7-15 at 6:30 AM Heart Rate 77 bpm. I have a sore wind pipe, mild hoarseness, and chest feels sore.
Pain and swelling at injection site.    Redness traveled down to bicep area.   Pain, weakness, in the bicep , red and blotches on skin over top of bicep
patient was administered vaccine as per EUA/standin order.  Approx 30 seconds after the vaccine was injected, the patient who was seated,stated she didnt feel well,  fainted and slumped forward in chair.  RPH who administered shot was able to catch her, keep her from further injury.  Approx 10 seconds later, she came to and was disoriented.  RPH explained where she wasand what had occured.  She complained of nausea, feeling hot and sweaty and numbness in fingers.  911 was called, and while waiting for EMTs to arrive she stated that she had had some similar reaction during a previous blood draw.  EMT arrived and transported her to local ER
This spontaneous report was received from a consumer refers to her daughter, a 12 year old female patient. On unknown dates by November 2013 the patient was vaccinated with GARDASIL dose 1, dose 2, dose 3 respectively (dose, route and lot# not reported). On unknown dates, in addition to injection site reactions immediately after receiving the vaccine (her "arm really sore"), the patient was "tired" and had "stomach ache and nausea". In December 2013, the patient started to have "migraines and gastroesophageal reflux". Migraines reoccurred on 16-JAN-2014 and 24-JAN-2014. The patient saw neurologist to seek medical attention but no medication administered. The outcome of the events was not recovered. Causality was not reported. Additional information has been requested.
Onset of follicular cystitis Severe inflammation and physical changes of bladder, urethra, extreme vulvar pain and initiation of many medications, two surgeries, 3 months out on disability. Chronic discomfort, very sensitive bladder (re foods, hydraton etc), frequent UTIs sometimes with blood in urine). Considerable pain during flare ups which require strong pain meds. Ongoing for nearly 2 yrs.
Information has been received from a pharmacist concerning an adult male who in approximately 2003 was vaccinated with a 0.5 mL second dose in the right thigh of varicella virus vaccine live. On 20-SEP-2005 a varicella titer was drawn that did not show seroconversion. It was reported that the patient had no symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Has been getting the flu for 50 years.  Given high dose flu vaccine. Not told. Fever 103 degree, chills, body aches , heart palpatation, trouble walking, dizziness, fatigue, couldn't eat.
2 weeks of headaches, intermittent fatigue, low-grade fever, nauseas that has worsening in the past 12 hours with fever 101.3, significant fatigue, low appetite, sore throat and mild cough.
Local-soreness, pain, swelling, redness. Systemic-lethargy-general malaise-mouth and throat soreness.
Received  1st vaccine 12/23/20 and 2nd 1/13/2021.  On 7/21/2021 developed symptoms of COVID and on 7/23/2021 tested positive for COVID 19
This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), AMLODIPINE BESILATE (NORVASC) and POTASSIUM CHLORIDE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F). At the time of the report, RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) fever of 100.1F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter.
The evening of having dose 2 I had body aches, headache, sore throat, coughing and it was like everything in my head was watering. I hurt so bad and when I would breathe it was like I was wheezing when I would take a deep breath and exhale I would wheeze and rattle way deep into my lungs. I also had a lot of pain and exhaustion.
Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
Issues after receipt of vaccine; was hospitalized and has health issues now.; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Company comment-This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction (reported as Issues after receipt of vaccine; was hospitalized and has health issues now) which occurred on an unknown date after receiving unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. No further information on clinical course, lab. reports, treatment received and details pertaining to vaccine doses was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction (reported as Issues after receipt of vaccine; was hospitalized and has health issues now) which occurred on an unknown date after receiving unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. No further information on clinical course, lab. reports, treatment received and details pertaining to vaccine doses was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient family member called later that day and stated that she was feeling very ill (did not specify symptoms) and that she was being brought to her physician for evaluation
2 days p/vax pt devel vomit, diarrhea & fever; hosp on 2/15; disch; then re-admit p/sx returned
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/9/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
devel red blotchy rash & lip swelling, heavy breathing;inc BP;had EKG done;02 sat & put on pred x 5 days & DPH;
The COVID-19 symptoms I had lasted 3 weeks and it hung on to my upper nose. I had it in my chest and would spit up blood at some points. I was very stuffed up and contacted my Allergist. I had lots of headaches and I'm used to migraines which I get a lot of. My GI was very upset at first and I had bad diarrhea. And it really tackled my head and nose, and made me very fatigued. I'm still dealing with fatigue now. I received the infusion but it made things worse. Right at the end of COVID-19 I felt very sensitive in my rectum with bowel movements. I went to the doctor when I started getting low grade fevers. They sent me to the GI and they found a perianal abscess and had surgery for that. Then I got C-diff that was resistant to medication. It finally went away the first of September.
Fever the evening the vaccine was given of 105. Temp lasted 36 hrs. Child irritable but consolable. Didn't want to bear weight on (L) leg for 24 hrs.
BP raised 04/06 SYS:150-160 DIA: 100. Continued with high BP through 04/07 early AN at which point BP began to lower throughout the day. Experienced Tachycardia -> 150 bmp lying down accompanied by chill on 04/07 early am hours.   Also experienced tingling in feet and legs that began 04/06
pt recvd vax & has sz; was shaking; eyes rolled back; high fever; to er;
I had vaccination on 09/17/21. I had started Chemo 08/03/2021 for bladder cancer that had spread to my lungs. On 04/20/2022 I had a mild sore throat. I had a PET scan on 04/21/2022. On 04/23/2022 I had a fever 101.3. I took a at home test on 04/23/2022 and it was COVID-19 Positive. I went to the emergency room on 04/23/2022 and gave me monoclonal antibodies and Tylenol. I am unsure if I had my flu shot at the same exact time as my 4th vaccination.
PATIENT STARTED TO FEEL DIZZY. I TRIED TO GIVE HER FLUIDS AND SOME SOURCE OF CARBS BUT SHE STILL FELT DIZZY. SO I TOOK HER TO THE URGENT CARE NEAR BY.
Pt developed pain to left upper arm (deltoid) 1 day post vaccination. Two days later the pt developed redness to area 7cm in diameter. Treated with Keflex.
12 hrs p/ acel-DPT, pt became pale, had dry heaves, cold clammy skin, became limp & unresponsive 2-3 min. afebrile.
11 year old patient inadvertently administered the Flublok vaccine, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2019SA262695 (same reporter)  This case involves a 11 years old female patient who was inadvertently received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1913, expiry date: 29-Jun-2020) via intramuscular route in the deltoid NOS on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) on 16-Sep-2019 for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.  The patient had no adverse event at the time of this report.  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.  List of documents held by sender: none.
12 narrow broken blood vessels under my breasts; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included stage 4 metastatic bone cancer and patient was undergoing treatment. The patient was allergic to penicillin. Concomitant medications included apalutamide (ERLEADA) for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 10Mar2021 at 14:00 (at the age of 70-years-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 01Apr2021 at 12:00, the patient experienced 12 narrow broken blood vessels under breasts. The patient did not receive any treatment for the event. The clinical outcome of the event narrow broken blood vessels under breasts was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
after the 1st dose of the vaccine, she experienced pain in the arms; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller was scheduled the 2nd dose of the vaccine tomorrow, on an unspecified date and was asked whether she needed to do a signing up just like the 1st dose before, after providing the information that she needed to call the facility, the caller gave information that, after the 1st dose of the vaccine, she experienced pain in the arms on an unspecified date. The outcome of the event was unknown.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
patient given pfizer instead of moderna as booster/3rd dose/additional dose...patient did not have covid card at time of shor and patient and patients rep assured us it was pfizer then presented after shot given with card w/ moderna listed
Off label dosing (second dose received beyond vaccine schedule); This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)). On 13-Jul-2021, OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283243.   Reporter did not allow further contact
fever of 100 f from 8 pm to 4 am. Extreme fatigue, should not get out of bed, cold sore outbreak the next day, headache, muscle pain, brain fog for a few days after. Red itchy arm at injection site.
Started to sweat, thought losing mind, freezing cold, body would not keep warm. Went to doctor who sent me to a specialist who ran test-endocrine system was off. Been on testosterone injections ever since.
Within minutes of vaccine, slight taste in mouth, otherwise only a slightly sore arm and no appetite. Within 12 hours, sharp pain in both knees, right ankle, right wrist; throbbing right arm, dizzy/vertigo, very rapid heartbeat. Within 24 hours, bedridden with low grade fever, continued dizziness, very rapid heartbeat, headache, but no joint pain. Within 36 hours, still rapid heartbeat with erratic pulse at times, and no appetite. Within 48 hours, heart rate beginning to slow somewhat, increasing with exertion. By 72 hours, heart rate finally back to pre-vaccine rate. Six days after injection, dizziness returns. On seventh day, dizziness is gone but still no appetite. Funny taste persists. Anticipate post-vaccine issues to continue until day 10, same as first dose.
Patient was complaining of a little soreness at the site on left arm and no redness until the third to fourth day after the immunization. It started to become red and swollen. That is when she went to her primary care physician. Her doctor gave her Keflex, thinking it was an infection and told her after she takes it, if the redness is still spreading that she was to go to the emergency room. Patient only took for three doses and noticed the redness was still spreading and was warm to hot to the touch so she went to the emergency room. She reported that she had no fever, no headaches, but she did feel a bit tired, had a decreased appetite, and mild soreness at the site of the immunization. The redness was raised and blotchy at the site.
No adverse event; she mentioned that a 9 month old was administered GARDASIL 9 on 25Aug2022; This spontaneous report was received from a physician and refers to a 9-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-AUG-2022, the patient was vaccinated with a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #U029033, expiration date: 13-MAR-2024 (dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
I had painful arm for 4 days, and a headache and bloodshot eyes that lasted two days. This was not as bad as the previous reactions I had to my Moderna shots, which induced full-on flareups of my Relapsing Polychondritis. Nevertheless the sore arm, bloodshot eyes, and headache seem worth reporting.  I received this Moderna booster on Friday October 21, 2022 after breaking my ribs on Tuesday, October 18. I did not wish to have a severe COVID infection shortly after breaking two ribs. It is now November 4, and I did not catch any respiratory infections, so the pain and malaise after the shot appear to have been worth it.
Dose #1 01/27/2021 Moderna 011M20A  pt has covid 19 8/9/2021