chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose #1, 3/2/2021 @ 3:30pm, while getting shot the site bled a lot and lump formed on arm, felt warm, after 15 minutes nurse said site looked Ok and didn't feel warm, so I was released.  Arm was slightly sore when raising arm or pressing on site. Day 1 after injection, 3/3/2021, bruised at injection site and sore to touch. Day 8 after injection, 3/10/2021,  Site area still bruised (yellow/green) that evening, began itching around right outer edge of bruise, applied Lanacane after shower. Day 9 after injection, 3/11/2021, Overnight I didn't sleep well, when I awoke, red bruise where it first itched and below that.  Bruise is larger in area and more color to it.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of VAQTA (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
New irregularity in menstrual cycle. I've never been late on my period in my life. Since receiving the vaccine I am late on my period by several days.
herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 70-year-old female patient (pt). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2015, pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) by the pharmacist for for the long-term prevention of shingles and zoster-related conditions. Pt was treated by a healthcare provider at hospital for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Resident received COVID-19 Moderna Spikevax as her 6th injection and keep her up to date on 11/14/2023 at 1pm. On 11/16/2023, Resident was noted to have edematous, red area from her L deltoid down to her elbow. NP was contacted and Resident was prescribed Pepcid 20mg daily x 2 days, Benadryl 50mg daily x 2 days, and Zyrtec 10mg daily x 2 days. Resident is currently being treated for the adverse event. Pharmacy has been notified and Spikevax has been added to this Resident allergies.
Baseball sized red rash at injection site, 8 days after injection. Area is swollen with a hard knot, red raised circular rash, itching and painful to touch
I woke up and my left eye is swollen and my face is kind of swollen; I woke up and my left eye is swollen and my face is kind of swollen; rash/ rash on and off on my back and on my arm and around my face; allergic symptoms; kind of like itchiness on my ears and my scalp and also like on and off on my back and also on both of my arms like my wrist area on both arms/All night I was up with scratching my face; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of followup information on 20Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician (patient). A 30-years-old female patient received first dose bnt162b2 (BNT162B2), intramuscular on 2020 at single dose for covid-19 immunisation. Medical history included On nose, had prior to getting the vaccine, was experiencing some kind of she got through the contact dermatitis rash like her arms and behind her ears and it was all over her neck (she thought it was related to mat because she was getting it on neck and ears taking medication for that it just allergy medication and it had gotten better). There were no concomitant medications. The physician reported she have been experiencing some allergic symptoms following it since Dec2020, she had itchiness, it was like a rash on and off on back and on arm and around face and itchiness on calp and face/ experiencing kind of like itchiness on ears and scalp and also like on and off on back and also on both of arms like wrist area on both arms and then in the morning like 20Dec2020, it was kind of all night she was up with scratching face,; In the morning 20Dec2020, she woke up with some mild facial swelling, noticed like eyes swollen and little bit droopy. The events were still going on, she just took medicine for it. It's kind of persistent. Physician stated, "I guess I can report the worsening of my symptoms that was in the morning of reporting date like 8 AM." Treatment included just took medicine, Prednisone, Benadryl and Zyrtec. Weight: About 103. The event outcome was not recovered.  Information on lot/batch number has been requested.
Patient said  she got vaccine on friday and started symptoms on thursday the following week. She had extreme dizziness and went to urgent care, they checked everything but everything seemed to be fine.
Patient reports having minor lip swelling after 12 hours ; then after 48 hours hives
Case of Myocarditis. Symptoms of dizziness which led to fainting. Heart rate out of control reaching over 200 bpm. Rushed to ER and admitted in ICU for a couple of days.
My breast milk dried up; My breast milk dried up; My breast milk dried up; This is a spontaneous report from a contactable other HCP (patient).   A 25-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 06Oct2021 (at the age of 25-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was none. No known allergies.  The patient's concomitant medications were not reported. Patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks: Prenatals. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced her breast milk dried up (disability) on 07Oct2021 with outcome of not recovered. No treatment received for the event. Event resulted in disability or permanent damage. The clinical course of events was as follows: My breast milk dried up. She was producing 25+ ounces a day with him feeding as well, now she was barely producing 5 ounces a day without him eating. Everyday her supple ts worse and worse. Sha has tried power pumping, everything to get it back and nothing. She was given no education on the vaccine while breastfeeding even though she clicked that box that asked if she was breastfeeding or pregnant. Covid was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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
Unsure if vaccine related. Received vaccine on 3/6/21.  On 5/21/21 I started having abdominal pain followed by coffee ground emesis and multiple bouts of large amounts of bloody stool. In the morning, on 5/22, I woke up dizzy, light headed, and tachycardic.  Went to the ED where I was admitted to the hospital. Initial vitals were T 98.1, HR 159bpm, RR 16, BP 132/93.  Remained in hospital until 5/27. Received IV fluids, Protonix, Carafate, Zofran, Compazine, Norco. folic acid, thiamine, Venofer, potassium chloride, and a blood  transfusion while hospitalized. Diagnosed with iron deficiency anemia due to acute gastrointestinal hemorrhage.
Subsequently post vax, the pt developed a reddened area at the injection site. No treatment was given. This adverse event resolved after 1 1/2 weeks.
Patient who is 12 years old and 2 months was given the pfizer dose for <12 year olds (this was her first dose)
p/vax pt reported hives on legs & abd;T99.5;3hr post vax T101.5;rash gone by AM;c/o achy joints & some chilling in evening;cough & cold sx;itching;
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 60 years old male patient who experienced he had problem lifting his left arm, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PNEUMOVAX 23 for Immunisation on an unspecified date (reported as same-day). On 02-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6310NA; expiry date: 20-Jun-2019 via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious he had problem lifting his left arm, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was he had problem lifting his left arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for he had problem lifting his left arm.
I started having headache and lasted for about a week. I couldn't sleep and very painful. 4/25/2021 My left ear started to feel wet. This is when I went to doctor and identified as shingles. I couldn't eat or drink and by 4/28/2021 my face started to paralyze so my doc ordered an MRI on 4/29/2021. I cannot work because balance and was feeling fatigue and tired. Even today, my face is still partially paralyzed and feel uncomfortable and mild pain in hear and/or ear.
Pt states she got up from exam table, sat down in a chair, vision became blurry. She woke up on the floor. Pt was found sitting in waiting room. Assisted back to exam room. BP x 2 90/60 10 min later 110/70 P60. Examined by Dr.
Heart rate increased and experiencing  little palpitations. paramedics came over checking out rates and back to normal about 5 minutes
Narrative: Patient received second dose of Pfizer vaccine on 4/13/21 at 12:00. Later that same day (around 21:00) patient presented to hospital and was diagnosed with mini-stroke - patient admitted to hospital for 2 days and is currently following with PCP. Patient with multiple comorbidities that would put him at high risk for TIA/stoke.
Tightness in chest (left sided), tightness at site of injection and in left shoulder. Difficulty getting breath unable to take deep breath. Dizziness, headache, treated at hospital ER with SoluMedrol 125mg IV Xopenex breathing treatment, Benadryl 25mg IV and Stadol 1mg IV x2.
pt recv vax 18OCT95 & devel swelling on the forearm & low grade fever (99.5-99);no further details were provided;
This case was reported by a nurse and described a 40 year old male subject who had a decreased response to vaccination with Engerix-B. The subject's medical history included non-smoker. On 02 February 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 17 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Pt presented to the ER 12/5/2021 complaining of altered mentation, decreased appetite, weight loss of 20 lb over 1 month.  Patient also having urinary incontinence.  Patient had been refusing to eat.  Patient's husband present at bedside.  Husband and patient's son who both live with the patient are both positive for COVID-19.  He stated that patient has been getting worse over the last month complaining of generalized pain all the time.  He was unable to care for the patient so he called ER.  Patient also had a cough that been going on "for a while", at least 4 months.  Patient had been having increasing weakness.  On 12/11 Overnight patient developed hypoxia and needed 5 liters supplemental oxygen. CXR showed right perihilar and basilar atelactasis and increasing left lower love airspace disease with small left pleural effusion. She received decadron, Patient was having congestion, which is slowly getting better, which I hope will continue to get better as she recovers from COVID-19. She is on Mucinex DM and Claritin. Her oxygenation issues is resolved and now she is off supplemental oxygen and saturating in 90s on RA.  Due to complication from other chronic illnesses, pt passed away on 12/24/21
02/21/22 presents to ED for "generalized fatigue and rapid heart rate'. PMHx of "myelodysplastic syndrome status post stem cell transplant"
Ezcema flare up, was dormant (no spots) day of injection, and then over the next 24 hours I had a huge patch on the arm of the injection site 3 inches long and 1.5 inches wide. No eczema anywhere else, just the arm that had the injection.
FLUZONE QUADRIVALENT was administered instead of the FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who administered fluzone quadrivalent instead of the fluzone high dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided.   On an unknown date, the patient was administered fluzone quadrivalent (Influenza Quadrival A-B Vaccine) at dose of 0.5 ml instead of the fluzone high-dose quadrivalent with no reported adverse event (wrong product administered) lot number not reported via unknown route in unknown administration site for Immunization.  Caller states if it is acceptable to give the additional influenza vaccine or if they can administer more of Fluzone to equal to the dose of the High-Dose. This situation is reported as a medication error due to administering the wrong vaccine.  Action taken: not applicable.  Outcome: Unknown   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 the 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.
Information has been received from a physician concerning a 71 year old female with hypertension and osteoporosis who on 27-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot 651320/1008P). The patient was concomitantly vaccinated in the other arm with a dose of varicella-zoster virus vaccine live (MSD) (lot 652936/0981F). On 27-OCT-2006, post vaccination, the patient's arm was red and swollen all the way down to the elbow. The patient received unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
her lymphedema on her right arm became a cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (her lymphedema on her right arm became a cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029L20A) for an unknown indication.     Concurrent medical conditions included Lymphedema (lymphedema on her right arm for several years). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ATENOLOL, FLUOXETINE, ISOSORBIDE MONONITRATE, NIACIN, RANOLAZINE, METFORMIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (her lymphedema on her right arm became a cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (her lymphedema on her right arm became a cellulitis) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.   As treatment patient took antibiotics (Doxycycline Monohydrate) 100 mg and also a Ceftriaxone injection) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of this event, 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 this event, a causal relationship cannot be excluded.
Diarrhea for 2 days, which could not be connected to anything eaten or any other factors. So suspecting side-effect of the COVID shot
pt recv vax 8JUL96 & w/in 2-3hr pt exp pain & swelling in the lt side of neck, shoulder, breast, & back;tx ice & motrin;
About 10 min after receiving Moderna Booster, patient fainted. Her eyes rolled back & she passed out.
Pt sts she started feeling "FLUISH" at 2 pm-followed by several bouts of N/V/D - unrelieved with PHENERGAN supp-went to ER-tx'd with IV fluids and meds.
66-year-old woman with a past medical history of rheumatoid arthritis, fibromyalgia, hypertension, hyperlipidemia, GERD and recent COVID-19 vaccination who presented from home with vomiting and altered mental status.  Patient was reportedly in her usual state of health until receiving her second COVID-19 vaccination on 3/24/2021.  She reportedly developed the above symptoms and her son called 911.  She was brought to the ED for further evaluation and management.  In the ED, routine vital signs were obtained which revealed patient was febrile to 103.6, heart rate 80, respiratory 18, blood pressure 116/73, O2 saturation 91% on room air.  Routine labs were obtained which revealed a normal CMP with the exception of a GFR 47, creatinine of 1.2, lactic acid 1.8, white blood cell count 6.1, hemoglobin 12.2 and platelet count of 144.  Urinalysis was obtained and was suspicious for UTI.  Rapid influenza and COVID-19 antigen were both NEGATIVE.  Blood cultures were drawn in the ED.  Chest x-ray revealed a suspicion for infiltrate involving the right upper lung and right perihilar region.  CT of the head no acute findings.  Patient was felt to have signs and symptoms consistent with pneumonia, and received IV azithromycin and ceftriaxone. Follow up chest xray the following day showed resolution of the right upper lobe findings arguing against pneumonia. Antibiotics were stopped and the patient was discharged home after a 1 day stay.
Paleness, syncope, lightheadedness, fainting/passing out, low blood pressure. Refused ambulance help and ER. Blood pressure fell to 88/59 initially then after 30 minutes and drinking some vitamin water and fanning patient's blood pressure recover to over 100/69 and regain some complexion on her face. She waited additional 30 minutes before she said she was back to normal
RTC 5 1/2 hours later with hives and itching. Treatment 1/2 tsp. Benadryl.
My arm was sore. I could not left it up. I had a red spot where the shot was given to me. I went to bed. I wake up and did not feel like I could eat. I had pain in my stomach and was vomiting. I had diarrhea. I started running a fever of 101. I was also very dizzy. I try to contact my doctor and could not get ahold of them. I went to an urgent care for care. They did a physical exam on me. My blood sugar was evaluated. These symptoms lasted about 12 hours.
patient received covid vaccine no.1 in April. He recieved 2nd dose last week.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
7/18/2022  She had a headache and I gave her some Ibuprofen. The next couple of days she would complain occasionally about a headache and sore throat, no fever or other symptoms. On 7/21/2022 she began having a runny nose and congestion and continued having a sore throat and headaches. 0n 7/22/2022 I took her to the doctor, and they said she looked okay. We started her on Zyrtec that evening.  An at home COVID test on 7/24/2022 which was negative. She is still having a runny nose and has not complained of a headache or sore throat for the last few days.
Hot flashes,I just turned 29 and I am having night hotflashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 01:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovary syndrome" (unspecified if ongoing); "Mushroom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset 10Nov2021 12:00, outcome "not recovered", described as "Hot flashes,I just turned 29 and I am having night hotflashes". Therapeutic measures were not taken as a result of hot flush.  Additional information: The patient did not receive any other vaccine within 4 weeks and did not receive any other medications in two weeks. 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 had other vaccine details included Pfizer, on 08Nov2021 administered in arm right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Insomnia, muscle and bone pain, constipation, anxiety, tremors, changes in skin texture, migraines, headaches, change in emotions, memory loss, fatigue, confusion
Information has bee received from a consumer concerning her 17 year old daughter with no medical history and an allergy to sulfa, who on 28-SEP-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and homeopathic medications (unspecified). Prior to being vaccinated with Gardasil the patient was tested for HPV and genital warts and all her test came back negative. On 15-OCT-2007 (also reported as 19-OCT-2007) the patient experienced a fever, and broke out with white bumps that were diagnosed as genital warts. The patient was treated with an unspecified medication. Approximately one week later the patients genital warts had completely went away. The patient was seen by the physician. A blood test for HIgG and IgM were performed (no results provided). The patient recovered on an unspecified date. Additional information is not expected.