chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sixteen year old, female received a yellow fever shot on Friday afternoon (13 Oct 2023) as a precaution for travel in December. She developed a small, localized rash on the third day (15 Oct 2023) at the injection site that developed into a larger, 3"x3" localized rash with defined edges and a bright pink color by Tuesday (17 Oct 2023).  The rash did not  change size or shape from this point forward, but did change color and texture, taking on an orangish tint with visible small blisters developing by 19 October 2023.  Parent provided photos to vaccination clinic technician and on-call pediatrician to rule out concerns for larger issues.  Other than the rash, she has not had any fever, headaches, or respiratory issues commonly associated with yellow fever leading the doctor to determine that the rash was non-threatening.  Patient was advised to keep the rash clean and covered and monitor for any changes.
Severe headaches several days,muscle pain, extremely large amount of swelling, hardness, redness, warmth, itching, at vaccine site.
Large rash developed at the injection site 8 days following vaccination. Rash was swollen, raised, itchy and painful to the touch. Spread down the left arm over the course of 4 days from approximately 2" long by 1.5" wide to 6" long by 2.5" wide. Rash dissipated by the 5th day. PCP was notified but no tests or office visit resulted. It appears that "COVID Arm" is a documented reaction and considered harmless.
Initial unsolicited report received from a consumer on 14 October 2016. This case involves a female patient (age at event onset not reported) who was vaccinated with a dose of Fluzone QIV via intramuscular route (Batch number: UI678AB, expiry date: 30 June 2017; dose, dose in series and site of administration were not reported) on 06 October 2016. Information regarding patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination were not provided. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 07 October 2016, one day (reported as within 24 hours) following the vaccination, the patient developed severe headache. Patient required emergency room (ER) visit and was hospitalized. Laboratory investigation was not reported. Corrective treatment was unknown. On unspecified date the patient was recovered from the event. The patient discharged from hospital on an unknown date and duration of hospitalization was reported as 5 days. List of documents held by sender: none. Sender's Comments: This poorly documented case of a patient had severe headache following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine. Time to onset is compatible, but additional information regarding patient medical history, any history of migraine, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information role of vaccine cannot be assessed.
HR-BP;  tingling in lips;     HR-97- no SOB, no Swelling; O2-97
Rash in Groin area, day of injection,  took Benadryl cleared it up overnight   flare up 5 days later, have taken Benadryl again, now waiting  No other symptoms
Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with single dose by mistake. Concomitant therapy included Dtap (unspecified), IPV, OPV (unspecified). The mother and father of the child reported that their son should have received the HIB vaccine (not specified) "but instead (was) given Gardasil. On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that oral electrolyte maintenance (PEDIALYTE) has been ordered. She added that on 16-MAR-2007, the haemophilus influenza type B vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01289). Additional information has been requested.
Hospitalized (1.6.22 - present - currently in ICU);  COVID-19 positive (1.6.22);  fully vaccinated (no booster) Admission date - 1.6.22:  Brief history and medical decision making: 76 y/o F with PMHx of HFpEF, rheumatic fever s/p mechanical MV replacement on warfarin, CAD s/p CABG, CKD3, COPD who presented with worsening SOB and hypoxia in setting of positive COVID test 10 days PTA. She is admitted for acute hypoxic respiratory failure. Also found to have AKI on CKD3 and supratherapeutic INR. Patient's SOB improving with placement on HFNC. Will continue dexamethasone. Hold on remdesivir as pt received monoclonal antibody 2 days PTA and has eGFR < 30. Continue HFNC, wean as tolerated. Supportive care. Give gentle hydration and monitor renal function. Pt given vitamin K in ED, monitor INR. Hold warfarin but plan to resume once INR is at goal range of 2.5-3.5. ASSESSMENT / PLAN: Patient is a 76 y.o. female with a PMHx significant for rheumatic fever s/p mechanical mitral valve replacement on warfarin, HFpEF diastolic dysfunction, CKD III, CABGx1, CAD, HLD, HTN, COPD, CVA, essential tremor, microcytic anemia, hypothyroidism who presents with acute hypoxic respiratory failure in the setting of worsening SOB after positive Covid test 10 days ago.   AHRF Covid-19 pneumonia COPD Exacerbation Worsening SOB, dyspnea and cough, O2 sat 50% on home pulse ox today. Wheezing on exam. satting 91% on 30 L HFNC 60% FIO2.   Plan: -Decadron 6 mg x10 days -O2 supplementation O2 sat goal 90-904% -Albuterol breathing treatment now then 2 puff q 6 -Home Symbicort BID -Continuous pulse ox, tele -Tessalon for cough, saline nasal spray  -If significant O2 desaturation, obtain repeat CXR, D-dimer, consider CTA Progress Note - 1.18.22:  (sedated and intubated) Principal Problem / Chief Complaint Respiratory failure with hypoxia Admitted: 1/6/2022 11:05 AM Length of Stay: 12 days.  Assessment and Plan Patient is a 76 y.o. female PMHx notable for HFpEF, rheumatic fever status post mechanical mitral valve, COPD, CKDIII, CAD s/p CABG x1, hypothyroidism who is admitted to the MICU for further management of acute hypoxic respiratory failure secondary to COVID 19 pneumonia and ARDS.  #  AHRF secondary to COVID-19 pneumonia Hx COPD Symptom onset 12/25, tested positive on 12/26, admitted on 01/06 and intubated 1/10.  Status post monoclonal antibodies on 01/04.  Vaccinated x2 but without booster.  Bronchoscopy with BAL performed 1/10. Negative for legionella and strep. Cultures NGTD. Plan:  o Tapering solumedrol, 30mg x3d (d2) o Lung protective ventilation; ARDS protocol o Completed 5 days Zosyn course o Continue COPD treatment:  Albuterol every 6 hours, Symbicort twice a day, Spiriva daily o Diurese to goal net negative 1L- Lasix 80mg TID o Renal function stable # Leukocytosis  WBC remains elevated but stable.Afebrile overnight with stable map. Continue to watch
Pt. fainted after receiving flu vaccine. Pt. also urinated when she fainted. Mother said she is prone to fainting but never this bad. Pt. was about to fall off of chair but her mother and I caught her and reposition back in the chair. pt. didn't respond to smelling salt and 911 was called. pt. came to as the paramedics arrived. she was very agitated and upset. The paramedics took her vitals and tried to calm her down and then put her on a stretcher. They took her to hospital ER.
Numbness and tingling in arms, legs, and face. High blood pressure and nausea.
woke up in hot sweat, couldnt swallow or walk straight, diagnosis stroke in medulla, been in rehab at encompass for two weeks and still doing therapy twice a week.   Patient described feeling like eyes were going to cross the day after third vaccine which is day before actual stoke (couldnt concentrate)
Went to Emergency Room. Arm throbbing, sore, fever, pain, advised that I had allergic reaction. Would have to wait out, take benadryl. next day went to Dr that said allergic, take benadryl, could take 2-4 weeks to subside.
pain my right shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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: Bnt162b2 (Dose 1, single, lot number and expiry date not reported), administration date: Mar2021, for Covid-19 Immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain my right shoulder".  The lot number for bnt162b2 was not provided and will be requested during follow up.
bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.
"bad reaction"; full blown flu-like symptoms; nauseated; feels achy; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches). At the time of the report, VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient was not having sweats.
This report was identified from a line listing obtained on a request by the company from Food and Drug Administration (HA# 757821) under the Act and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with GARDASIL 9 (lot# N025428 and expiration date 19-JUN-2020), intramuscular in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (lot# 9PD92) intramuscular in the left arm and MENVEO (M17033) intramuscular in the left arm. On 09-JUL-2018, the patient experienced dizziness, injection site swelling, injection site pruritus, hypersomnia and fatigue. The patient was treated with BENADRYL. The outcome of dizziness, injection site swelling, injection site pruritus, hypersomnia and fatigue was reported as not recovered. Causality assessment of the events were not reported.
Vaccine Administration error. The Vaccine was given beyond 30 day refrigeration quidelines.
24 hours after the vaccine I developed HIVES on my right LEG from buttocks to just above the knee .. hives subsided except for the largest one,.. turned bright red (almost looks like a burn)  i have taken pictures of the progression each day.  Also have a warming/burning type sensation on the inside of the same leg/thigh area.
3 inch diameter red rash at the injection site; 3 inch diameter red rash at the injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3 inch diameter red rash at the injection site), VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site) and MYALGIA (Soreness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient was on cancer remission). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (Soreness). On an unknown date, the patient experienced VACCINATION SITE RASH (3 inch diameter red rash at the injection site) and VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site). At the time of the report, VACCINATION SITE RASH (3 inch diameter red rash at the injection site), VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications also included supplements and drug for cancer remission. No treatment information was provided.
White circle with redness of perimeter, warmth, itching. Redness measures 7.5 cm W x 8 cm L.
Patient received a Rabies vaccine in one arm and in the other arm received Menactra and Hep A. After the Hep A patient became very rigid, experiencing seizure like activity. Provider was immediately notified and evaluated the patient.
Received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine after the 6 hour vial puncture expiry) had resolved.        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.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 012M20A, with no associated AEs.
This case met criteria for vaccine breakthrough review. Symptoms include chest congestion, cough, sore throat and back pain.
pt devel a mod severe case of varicella covered head to toe w/pox;no prev nor hepatitis;
Fever 101.0 on 11/10/18 in the office per mom, pt c/o HA, sore arm after injection swollen lips and both arms numbness.
Discomforts subside; General stiffness; Mild aches; Soreness and stiffness at injection site; Soreness and stiffness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Jan2022 10:15 (Lot number: FL3197) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Administration Time: 13:00; Anatomical Location: Right leg; Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site"; Bnt162b2 (DOSE 2, SINGLE; Lot Number: EP6955; Administration Time: 11:00; Anatomical Location: Right arm; Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 58 years old, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 12Jan2022 19:00, outcome "recovered" (13Jan2022 12:00), described as "General stiffness"; PAIN (non-serious) with onset 12Jan2022 19:00, outcome "recovered" (13Jan2022 12:00), described as "Mild aches"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 12Jan2022 19:00, outcome "recovered" and all described as "Soreness and stiffness at injection site"; DISCOMFORT (non-serious) with onset 13Jan2022 19:00, outcome "recovered", described as "Discomforts subside". Therapeutic measures were taken as a result of musculoskeletal stiffness, pain, vaccination site pain, vaccination site reaction, discomfort.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior vaccinations (within 4 weeks) was none. Specific relevant test for thromboembolic events with thrombocytopenia was none. Only treatment (13Jan) was 400 mg Advil.  No follow-up attempts are possible. No further information is expected.
The patient returned to the pharmacy a couple days later with redness and selling around her deltoid. Patient stated it was warm to the touch and she was also experiencing nausea. She is following up with her primary care provider to ensure it is not an infection. Patient was provided with the information sheet and she read it prior to the vaccination.
MOUTH SORES AND ULCERS; PAIN @ INJECTION SITE (LEFT LEG), SWELLING @ INJECTION SITE, REDNESS ( 2 INCHES AND ENLARGING); HIGH FEVER 101-102f
Received MMR on right arm on 6-9-09.  6-11-08, right arm localized redness (4cm x 3.5cm), slight itching.  No pain.  Treated with 1% hydrocortisone cream BID prn itching.
Fatigue, pain in neck, shoulders, elbows, wrists, fingers, hips, knees, ankles, sore toes and muscle pains. Was unable to lie on side due to pain in shoulders and hips. Got very little sleep for 5 weeks. Stiffness in all joints made changing positions painful and difficult. NSAID have been used periodically for pain/stiffness.
Information has been received from a physician concerning her 15 month old son, with no history and no allergies, who on 6/9/2005 was vaccianted with a 0.5 ml dose of varicella virus vaccine live. Concomitant vaccine administered on the same day included a dose of diphtheria toxoid + pertussis vaccine unspecified + tetanus toxoid manufacturer unknown. Ten days later on 6/19/2005 the patient experienced tiny spots over his whole body, which became larger and then faded out. They later appeared as erythema multiforme but not typical varicella lesions. On 6/21/2005 the patient had a fever of 103F, which continues now on 6/22/2005 with new spots continuing to develop. The patient was treated with Ibuprofen (Motrin) and cetirizine hydrochloride (Zyrtec). It was reported that the patient has not recovered. No product quality complaint was involved. Additional information has been requested.
Fever (up to 103.0), body aches, tachycardia, headache, nausea, chills, fatigue, and loss of appetite for 2+ weeks. Seeked medical attention on Oct. 26. Awaiting results now from blood work, urine sample, chest X-ray, blood cultures, and flu swab.
The vaccine recipient is a breastfeeding mother. She received her vaccine on 04/05/21. On 04/08/21, her 11 month old son had new-onset seizure activity. The child was evaluated in the emergency department and hospitalized in the PICU for status epilepticus.
Pt vaccinated with Oral typhoid/Meningococcal developed edema & erythema of arm (site of inoculation) plus hx of lymphadenopathy.  Resolving @ 48hrs.
Large red swollen area at injection site. Itchy, hot and painful to touch. Have been applying ice pack on and off. Took benedryl capsule. No relief or change yet but tolerable.
Several weeks after the Pfizer Covid-19 booster, which was my first Pfizer vaccine as previous shots were Moderna, I experienced two episodes of tingling sensations across my chest when riding my bike, upper back and shoulders. I went to my cardiologist Dr. as reported above, and he conducted a stress test and echo cardiogram. The stress test showed possible blockage so I had a cardio catheter done by Doctor and this was negative for blockage but showed some arterial disease and I was prescribed I rosuvastatin. I renewed riding my bike and these strange symptoms persisted. Review of possible causes points to Thoracic outlet syndrome and I am going to see a neurologist about this. In parallel, following the Pfizer vaccine my hypertension has worsened and my related meds have been elevated. It is possible this vaccine caused these problems!