chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthropod bite; Anytime when got a bug bite or tick bite it was slow to heal; psoriasis flare-up on elbows, knees and right eyelid; temperature of 101.9; Swelling of wrists; Flare up in all joints after took first covid vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling of wrists), ARTHROPATHY (Flare up in all joints after took first covid vaccine.), ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal) and PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) in a 42-year-old male 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) solution for injection for Psoriatic arthropathy and Plaque psoriasis.    No other medical history was reported.  Concomitant products included CYCLOBENZAPRINE HCL, CALCITRIOL, TRAMADOL HCL, CLOBETASOL PROPIONATE, NAPROXEN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 wk. On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg,1 in 2 wk. In October 2021, the patient experienced ARTHROPATHY (Flare up in all joints after took first covid vaccine.). On an unknown date, the patient experienced JOINT SWELLING (Swelling of wrists), ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal), PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) and PYREXIA (temperature of 101.9). In 2021, ARTHROPATHY (Flare up in all joints after took first covid vaccine.) had resolved. At the time of the report, JOINT SWELLING (Swelling of wrists) had not resolved and ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal), PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) and PYREXIA (temperature of 101.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.9 No unit Abnormal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided. Since 2012, the patient had been taking Humira and stopped it in Jun 2021 because he was diagnosed with covid infection on 09 Jul 2021. He was hospitalized for five days with covid.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COVID, temperature was 101.9 after took first COVID VACCINE, Anytime when got a bug bite or tick bite it was slow to heal unknown onset was not provided.
Occurred within 6 hours and continue to occur 2 days later. Fever of 102 degrees, Chills, Nausea, Dizziness, Joint Pain, Loss of appetite, Vaccine site inflammation (muscle pain, swelling). Treated with asprin, tylenol, lots of fluid
tender breast tissue; sore muscles in both arms and neck; aches/pain throughout body and limbs; Terrible flu symptoms approximately 12 hours after vaccination.; Swollen lymph nodes in armpits; sore muscles in both arms and neck; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Lot number: FG3527) at the age of 64 years as dose 3 (booster ), single for covid-19 immunisation. Relevant medical history included: "Eczema bouts", start date: 2016 (unspecified if ongoing), notes: Eczema bouts - last serious in 2016; "Carrier of Staph, Non MRSA" (unspecified if ongoing), notes: carrier of staph, non MRSA. The patient took concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EW0165, previous dose administration date=27Apr2021, previous dose dose number=2, previous dose vaccine location=Left Arm), administration date: 27Apr2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=ER8727, previous dose administration date=25Mar2021, previous dose dose number=1, previous dose vaccine location=Left Arm), administration date: 25Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Booster"; BREAST DISCOMFORT (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "tender breast tissue"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Nov2021 12:00, outcome "not recovered" and all described as "sore muscles in both arms and neck"; PAIN (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "aches/pain throughout body and limbs"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Nov2021 12:00, outcome "recovering", described as "Terrible flu symptoms approximately 12 hours after vaccination."; LYMPHADENOPATHY (non-serious) with onset 27Nov2021 12:00, outcome "not recovered", described as "Swollen lymph nodes in armpits". Therapeutic measures were taken as a result of breast discomfort, neck pain, pain, influenza like illness, lymphadenopathy, pain in extremity.  Additional information: The patient did not take any other vaccine in four weeks of COVID vaccine. The patient took vitamin in two weeks of vaccination. The patient could barely walk the morning following vaccine. The patient was treated with 500 mg Tylenol to reduce symptoms. The patient had very sore arm and neck muscles as well as swollen lymph nodes in armpits 48 hours later. The patient did not had COVID prior vaccination and did not tested positive post vaccination. here were no known allergies.  No follow-up attempts are possible. No further information is expected.
I was given the pneumonia shot and a flu shot told not to worry about side-effects - By midnite I was in extreme pain & then suffered a seizure!
Patient is a 59 y.o. male how is here with rash since yesterday. The rash is described as painful and located on the left area of the patient's torso. The rash is bright red in nature and slowly got worse over time since yesterday.  Patient denies any fevers or chills. Patient has had shingles possible for his life. Patient got the shingles vaccine last week. The rash is getting more and more red. There is no nausea, vomiting, shortness of breath, or diarrhea, or other skin rash. Nothing makes the pain better or worse. The pain does not radiate. There are no other associated symptoms. Vitals: BP 119/75 | Pulse 66 | Temp 37 °C (98.6 °F) (Oral) | Resp 16 | Ht 1.727 m (5' 8") | Wt 99.8 kg (220 lb) | SpO2 93% | BMI 33.45 kg/m². General: alert, appears stated age and cooperative. Skin: Patient has an erythematous painful vesicular rash on the left torso corresponding to about the L5 dermatome. Throat: lips, mucosa, and tongue normal; teeth and gums normal. Mouth: No perioral or gingival cyanosis or lesions. Tongue is normal in appearance. Neck: Back: no scoliosis present, symmetric, no curvature. ROM normal. No CVA tenderness. Lungs: clear to auscultation bilaterally. Heart: regular rate and rhythm, S1, S2 normal, no murmur, click, rub or gallop. Abdomen: soft, non-tender; bowel sounds normal; no masses, no organomegaly. GU: defer exam. Musculoskeletal: negative. Extremities: extremities normal, atraumatic, no cyanosis or edema. Pulses: 2+ and symmetric. 1. Herpes zoster without complication -valacyclovir for 10 days -return to clinic for worsening symptoms -continue lidocaine patches as needed for pain.
Pentacel and Acthib on the same day in error due to the wrongfully pulling the ActHib vaccine. with no reported adverse event; Pentacel and Acthib on the same day in error due to the wrongfully pulling the ActHib vaccine. with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician. (Reference number- 00647951) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 1 year old female patient administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: U6899AB and expiry date: 17-amy-2022) and 0.50ml dose of HIB (PRP/T) VACCINE [ACT-HIB] standard once (Lot number: UJ398AAA and expiry date: 06-Aug-2021) via intramuscular route in left thigh for prophylactic vaccination on 18-Jun-2021 on the same day in error due to the wrongfully pulling the ACT-HIB vaccine (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MEASLES, MUMPS AND RUBELLA VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency same day).  At the time of report, no adverse event was reported.  At the time of reporting, the outcome of both events were 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 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
Given Hep B #3.  Half hour later pt returned to APRN office complaining of itching at injection site.  urticaria right upper arm noted.  No systemic symptoms or respiratory distress vs. stable.  Resolved after 1/2 hour after Benadryl 25mg per mouth and ice.
Pt. rec'd 12 mo immunizations at WCE on 5/22/14. Nurse noted mild redness at LA site following MMR administration and reported to Dr. Pt assessed and Dr conferred with ID per phone and with red book. Observed x 30 min post vaccine. No systemic s/s - approximately 4cm x 3 1/2cm lt pink area decreased. Referred to allergy.
Three days after receiving a smallpox vaccination, patient was awakened at 3:00 AM with sharp, left pectoral pain.  This sharp pain continued intermittantly for nine days, and then resolved.  Due to recent reports of cardiac pain following receipt of smallpox vaccine, she was evaluated by a physician on March 31, 2003.
Mother stated that in 1 1/2 hr post immunization her infant had less than an hour of "odd breathing." She describes some wheezings "working at breathing."
PATIENT WAS COMPLAINING OF HAVING RASH ABOVE THE INJECTION SITE AND WRAPS AROUND THE BACK OF THE ARM.  TOLD HER TO TAKE TYLENOL AND PUT SOME ICE ON IT AS SHE WAS HAVING SOME PAIN.
Day after injection gradual emotional feelings. Feeling need to cry but didn't. 2nd day after vaccine started to feel nervous and found it very difficult to concentrate on my work. (I'm a teacher who sees pupils 1:1) Anxiety increased daily. Every task took enormous concentration. Felt weakness in my legs. Felt confused.For example:Looked down at horse chestnut kernel thought how prickly it was,went to pick it up, and said aloud "That's  hot?" Returned to classroom and instead of writing S for spelling program wrote U for a spelling programme I used many years ago. I had these symptoms  over a  2 wk period and thought I really needed to  retire until I started to wonder about side effects of flu jab because I felt like I did after cortisone  injections. I researched the adjuvant mf59
had them after I had the shot/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had them (shingles) after received the Shingles shot. The patient stated they just was not as bad. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Information has been received from an investigator concerning a 30 day old female with no concurrent conditions and a history of hyperbilirubinemia who entered a study. On 21-NOV-2006 and 19-DEC-2006, the patient was vaccinated IM with a first and second 0.5 mL dose of blinded therapy, respectively. On 25-DEC-2006, the patient was admitted to the hospital with a witnessed episode of arm and shoulder rhythmic jerking. The episode lasted approximately 30 seconds. The father stated that the patient was asleep at the time he noted the shaking. The father attempted to awaken the patient and stop the movements but was unsuccessful. Previously witnessed episodes occurred on 21-DEC-2006 and 24-DEC-2006. There were no recent anoxic, infectious, traumatic, or hemorrhagic injuries. There was no history of fever and no other signs of illness. The patient had a complete physical at the time of admission to the hospital on 25-DEC-2006 and no abnormal findings were noted at that time. Multiple tests were ordered and some results remain pending. A basic metabolic profile was within normal limits. Total bilirubin was 5.9, AST/ALT 75/64, blood cultures revealed WBC 7.2, hemoglobin 13.1, urinalysis was within normal limits, cerebrospinal fluid glucose 48, protein 85, WBCs 9, gram stain with a few segs, few leukocytes, no organisms seen, HSV PCR was negative and urine and blood cultures were pending at the time of discharge. The patient was found stable for discharge on 26-DEC-2006 with a discharge diagnosis of "sleep myoclonic activity." The patient was discharged home recovered, in good condition, and free of any symptoms. The reporting investigator felt that myoclonic sleep activity was possibly related to study therapy. The record for this patient was unblinded on 03-JAN-2007. The patient was treated with modified process vaccine.
Patient reports knot under injection site (induration) about the size of a quarter with minor itching.
Woke up the next morning with rust colored spotting on my hands that wouldn't wash off. Spots faded over 3 days.
lost consciousness; Severe cramping; diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. The patient has no known allergies. Patient is not pregnant at the time of vaccination. Concomitant medications included cyanocobalamin (VITAMIN B-12), Iron, and Vitamin D (VITAMIN D NOS); patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jan2021 04:00 AM, the patient experienced severe cramping, followed by episode of diarrhea. During the cramping, she lost consciousness for an unknown amount of time. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The events were reported as non-serious.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of lost consciousness cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available.  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.
PARALYSIS LEGS & ARMS 20SEP96;pt recv vax 12SEP96;rx ?-different facility;
Since 2 December he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on several occasions in early December where he was treated with oral antihistamines and oral corticosteroids. He reports when his symptoms first started he experienced episodes of throat swelling causing difficulty swallowing, nausea, and dizziness but since that time he denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 19 November, 13 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 18 (2, 2, 3, 3, 2, 3, 1, 2). No history of adverse reactions to prior vaccines.
1. There were NO REPORTED ADVERSE EVENT.  2. Vaccine was administered at 4 days past the UPDATED EXPIRY of 08/23/21 though still within vaccine PACKAGE EXPIRY date of 08/31/21.  3. Only filing as a VACCINE ADMINISTRATION ERROR report
Moderna COVID-19 Vaccine EUA  Fever, headache, body aches, chills
Headache, Myalgia, Immediate headache with injection. Thursday backache/muscle fatigue and lymphadenopathy started in left axilla. Saturday morning lymphadenopathy started in left side of neck.  Narrative:
Patient had uncomplicated pregnancy. Received the Tdap Vaccine at 35 weeks day 6. At 36 weeks and 2 days baby was delivered via emergency C-section due to fetal distress. Infant was transported to a NICU. Infant was diagnosed with...Ascites, Respiratory Insufficiency/Failure, Need for observation and evaluation of newborn for sepsis, Hypoalbuminemia, Proteinuria, Other primary thrombocytopenia, Adrenal Insufficiency, Gross Hematuria, Hepatic injury, Acute renal failure, congenital hypothyroidism.
On 4/30/00, went to doctor complaining of rash on back and chest. The doctor felt there may be a reaction to the vaccine. (Sister-in-law purchased vaccine Hep-B) at pharmacy where she works; brought it home and gave it to Ms. Nes.
NAUSEA, FAINTNESS, DIAPHROESIS LOW BP 84/151 RECHECK 15 MIN 114/79 P 70 02 97%
tingling in L arm & leg @ 4:18pm - Returned to facility Txment: none, observed, left 16:50pm - felt ok Allergy review not recommended 2nd dose 1/20/21 - no problem
Feel headache first days only, but last Sunday I was driving and I need to suddenly stop, because I was so dizzy, lightheaded , after this event this happened again today morning, but not like last Sunday, today was less . I don?t know if this is normal or not .
administered IPOL post excursion with no reported adverse event; temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event; Initial information received from on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who was administered ipol post temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) for Immunisation.  On 21-Sep-2022, the suspect IPV (VERO) was exposed to a temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event (product storage error).  On 23-Sep-2022, the patient received 0.5 mL total dose of suspect IPV (VERO) once (lot V1A022M and expiry date: 17-Feb-2024) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
I got the shot (first dose) on left arm at 4:30 PM with no immediate side effects beyond regular soreness at shot spot (like any other injection). But around 8:00 PM my left arm started feeling itchy. Mildly itchy. After scratching, the itchy parts got a bit Reddish but not a deep red, mode like a light red/pink.  Noticeably: inner elbow, back of upper arm, front of upper arm, and upper left shoulder/back. No noticeably swelling or raised areas/welts. No trouble breathing. No fever but I don?t have a thermometer to check. Not splotchy, more like if I?d used cheap fabric softener just on my left side. Not clearly distinct red/pink areas like when you google ?COVID arm.? Upper arm area overall, including left back and left chest, not specific to the injection site.
Headache, Fever, Diarrhea, shaking/chills, sore throat Narrative:
Td administered 9/18/02. Next day, noticed 6"x7" reddened, swollen, indurated upper left deltoid region described as painful. No CP, SOB, dysphagia, wheeziness etc. No fever.