chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot flashes then ached all over then large redness gradually developing over several days still with tenderness less rom left shoulder and fading area of swelling now 6 to 7 cm in diameter
menstrual cycle started 10 days earlier than normal. It was the worst cycles I have ever had. horrible cramping, strong blood flow which lasted 9 days. Usual cycle is only 5 days and is light.
Vaccination site pain; Administration site movement impairment; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Administration site movement impairment) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). 13-May-2021, the patient experienced ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Administration site movement impairment). On 14-May-2021, ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Administration site movement impairment) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Body temperature: 100.3 Farad (High) 100.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided . No concomitant medication were provided.   This case was linked to MOD-2021-132221 (Patient Link).
expired Daptacel was given to a 2 year old patient/No AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case is linked to case 2020SA053845 (same reporter).  This case involves a 24 month old female patient who was administered with 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA) via intramuscular route in the left thigh on 24-Feb-2020 for prophylactic vaccination that had expired on 07-Feb-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event reported.  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.
Information has been received from a consumer concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The consumer reported that she heard the patient had subsequently developed mumps. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown.
PT REPORTED SKIN INFECTION WENT TO URGENT CARE AND RECEIVED AN ANTIBIOTC
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. Approximately in 2012 (reported as approximately 1 year ago) the patient was vaccinated with ZOSTAVAX dose unknown for shingles prevention. No concomitant medications were reported. Approximately in 2012, 5 days after receiving vaccination the patient returned to the pharmacy as the patient had experienced unspecified rash. The pharmacist stated the rash as mile to moderate. The outcome of rash is unknown. Additional information has been requested.
Patient woke the next morning after the vaccine feeling exhausted. Nausea began later that day. It's 2 days post vaccination with no improvement or worsening of symptoms.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 08-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received a dose of RECOMBIVAX HB on 08-MAR-2014, that was exposed to a supported temperature excursion. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
started to experience headache, more than just a headache.  This captured my attention. Also started to note increase pain in hands, a more intense pain in  some digits as well. Made appointments with Neurologist, who after MRI said I had occipital headache and put me on Topiramate, and I take 3 pills every night. He also ran  blood tests and found abnormal  increased immune system sensitivity and referred me  to a   Rheumatologist  who after more tests , prescribed Hydroxychloroquine, which I now take daily. I never had these types of problems until I received the Pfizer COVID 19 vaccine. Now I have a right breast mass that was found on a recent mammogram just this week.
Myalgia, UrticariaPruritus, injection site pain/redness/swelling/itching, chills, fever, body aches, fatigue, swollen lymph glands Narrative:  Employee reports injection site pain/redness/swelling/itching, chills, fever, body aches, fatigue, and swollen lymph glands after receiving vaccine. No further information provided in report.
Pt reported headache, noted by nurse at School post vaccination to have sleepyness, tire, disorientated to time. Temperature noted to be 100.6. Estimated time vaccinated at school 10:30am and estimated time presented to nurse @ School was 11:30am. Pt was transported to E.R by ambulance from school, estimate arrival to ER 12:20pm. Mom reports that son told her he blacked out twice-before getting to nurses office. Mom states during ambulance ride pt had headache & vomited. Mom concernered pt might of been drugged. Went at E.R no temperature-temp wnl's. E.R physician ordered drug toxicity screen and pt had Cat Scan of Head. Mom states drug screen was negative and E.R doctor thought it of been reaction to flu E.R doctor thought it might of been peti mal seizure or cluster migraine. Mom states pt doesn't have seizure disorder. Mom states she reminds pt to eat in mornings since on ADHD medication of Vyvanse and that pt did eat in am. Mom reports pt has appt with neurologist on Wed, Oct 19th, 2022.
Severe body aches within 4 hours lasting for at least 2 days (still aching, but not as severe 2 days later), treated with Ibuprofen 800 mg every 8-12 hours as needed Fever - mild, beginning at 24 hours after shot and breaking about 12 hours later High Heart Rate - ongoing from 24 hours, treated with Metroprolol - heart rate up to 130 bpm when sitting, doing nothing Anxiety - high heart rate and fever contributed to an anxiety attack about 29 hours after immunization, other contributing factors were high blood pressure and dehydration caused from not taking normal meds and not drinking adequate fluids; taking meds and drinking water and lemonade helped relieve the anxiety Dizziness - extreme dizziness occurred at the same time as the fever and lasted until after the anxiety attack; it seemed to ease after eating dinner and drinking lemonade but never completely disappeared until the next morning
In early July 2002 the parents noted onset of a sustained period of developmental regression that though mild involved both motor and speech. The parents describe him as being detached and less responsive through the following months until December when he seemed to recover. They feel he has regained and exceeded prior progress in the last month. Parents noted developmental regression by mid July 2002.
I started to experience shortness of breath and chest pain, I tried to stay hydrated and took Motrin and Tylenol which made the symptoms manageable. After having the 2nd dose of the vaccine (February 16, 2021-Moderna-Lot#032220A) I started to have the shortness of breath and chest pain along with a rash from head to toe. I went to my PC provider and a dermatologist and they both agreed that this was a reaction to the vaccine. The dermatologist told me to take Claritin or Benadryl for as long as I needed so I took it for 3 months. I still have the rash but the majority of the other symptoms dissolved.
Not much of appetite; Tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired). At the time of the report, DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
Patient experienced itching and hives during observation. Redness was also noted to bilateral upper extremities and trunk. Vitals were within normal limits. Patient was given Benadryl 12.5 mg oral solution and dexamethasone 4 mg PO x 1 dose with water.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and genders. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (Batch, lot # K013861, expiration date: 18-MAY-2016), oral. Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has been requested (correspondence containing a request for additional information is scheduled).
patient is a 81 y.o. male w/ HTN, HLD who presented from outside hospital as direct admit on 7/28/2023 with NSTEMI and Covid w/ hypoxia.  Patient initially presented for syncopal episode, likely due to combination of dehydration and COVID-19.  At outside hospital, was found to have elevated troponins with positive and therefore transferred.  He was seen by cardiology, thought to be demand ischemia related to syncopal episode and COVID.  No concern for acute coronary syndrome.  Echo obtained which was unremarkable.  Recommends outpatient stress test.  Patient initially required O2 however was weaned to room air on time of discharge and overall otherwise minimal symptoms from COVID.  He was discharged .  He was discharged with Decadron.  We will follow-up with his outpatient cardiologist.  Additionally, patient found to have iron deficiency anemia.  Started on oral iron and recommending outpatient  endoscopic evaluation.         Assessment and Plan Syncope -No obvious cause. Possible contributors are mild dehydration, covid infection.  Low suspicion that this is a reflection of symptomatic bradycardia or other arrhythmia -Patient reports syncopal episode after driving to work.  No preceding symptoms -EKG with sinus bradycardia, first-degree AV block, similar to prior -Baseline heart rate seems to be around 5060.  He is on metoprolol -Monitor on telemetry, few PVCs.  V. tach and NSVT reported more likely to be artifact per cardiology -TTE findings below. Overall unremarkable -Encourage oral hydration NSTEMI -Suspect type II secondary to demand ischemia with syncopal episode/COVID.  Coronary calcifications noted on CTPA so possibly some atherosclerosis component -No noted history of CAD however patient does follow with a cardiologist Dr. at hospital for unknown reasons.  Denies prior ischemic work-up -Presented with syncopal episode.  Denied chest pain -Troponin 15>34>78>91>83 -EKG with sinus bradycardia, first-degree AV block.  No ischemic changes -TTE (8/28): LVEF 50+/- 5%, no wall motion abnormality, left atrial enlargement.  Pulmonary hypertension with RVSP 58 -Started on heparin at outlying ED -Continue ASA and statin -Cardiology following and recommending no further inpatient work-up.  Can follow-up with his outpatient cardiologist for Lexiscan Cardiolite stress test once out of COVID isolation   COVID Acute hypoxic respiratory failure, resolved -Symptom onset 7/26 with syncopal event, has mild cough and diarrhea.  Per patient family was having symptoms.  He is vaccinated -Tested positive at outlying ED and noted to be hypoxic -Started on dexamethasone 6 mg IV x 10 days (7/27) at outlier -Prn nebs and mucinex -He has been oxygenating well on room air for >24 without any respiratory symptoms other than a mild cough.  We will continue dexamethasone at discharge   HTN -Chronic, on metoprolol -BP stable -Continue    HLD -Chronic, on atorvastatin and fenofibrate -Continue lipid therapy at current dose.  May need to increase atorvastatin pending outpatient stress test.  Will defer to outpatient cardiologist   OSA Pulmonary hypertension -Noted pulmonary hypertension on echo with RVSP 58 -Compliant with CPAP, continue -On armodafinil, continue
Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by a dime size of mucous and then later a dime size of bright red blood. No history of rectal bleeding prior. Later in the had more cramping and passed addition medium BM with blood not in stool.  Noted for one day only. No idea if this is related to vaccine, but was an unusual occurrence four days after vaccine.
10 am brain fog first. Notable dizziness. Then stiffness in neck. Headache started. Then pain in joints and along spine. Chills sometimes severe. No fever. Was hesitant to take Advil but did at 6pm. Then kept up. Symptoms started to ease overnight. Lingering symptoms next day but not severe. Sore arm severe day following vaccine and lasted 3 days. Under arm swelling (arm pit) is bad and still present on Saturday 11/27. No improvement in that. Maybe getting worse. That is the only side effect remaining at this time.
The rash severity increased to open sores and increased redness; The rash severity increased to open sores; About 15 min later a large rash (mild) was found on the the infant's leg; breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (The rash severity increased to open sores and increased redness), PAIN (The rash severity increased to open sores), RASH (About 15 min later a large rash (mild) was found on the the infant's leg) and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son) in a 3-year-old male child exposed to mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) , while the mother received the product for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the child was diagnosed with ERYTHEMA (The rash severity increased to open sores and increased redness), PAIN (The rash severity increased to open sores), RASH (About 15 min later a large rash (mild) was found on the the infant's leg) and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ERYTHEMA (The rash severity increased to open sores and increased redness) and RASH (About 15 min later a large rash (mild) was found on the the infant's leg) had not resolved, PAIN (The rash severity increased to open sores) outcome was unknown and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Transmammary), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after.  The milk was stored and then given to infant son. About 15 min later a large rash (mild) was found on the the infants leg. The rash severity increased to open sores and increased redness.   It is unknown if the patient experienced any additional symptoms/events.   Reporter did not allow further contact
No additional adverse event reported.; Nurse calling to report an adverse event on improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T023919, which has been verified to be valid, expiration date reported and validated as 09-JAN-2022). The vaccine administered, experienced a temperature excursion of -5.2 degrees Celsius (C), for a time frame of 15 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Patient reported increased nausea & headaches beginning appx. 2 hours after injection. Condition worsened into fever, joint pain & aches, chest pain & shortness of breathing over the next several days. Fever has abated at time of reporting (8 days post injection), although, aches, pain & shortness of breath remain.
Body aches; Very Achy; Swollen Lymph nodes; Nausea; Pain at injection site; Prev dose administration date: 25Apr2021/ Administration date: 02Oct2021; Horrible headache; Extreme fatigue; Had sore left arm; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 14:45 (Lot number: FD0809) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: POTASSIUM. Vaccination history included: Bnt162b2 (Prev dose Brand: Pfizer BioNTech, Prev dose Administration time: 11:30 AM, Prev dose Vaccine location: Left arm, Route of administration: Intramuscular, Lot Number : misplaced/discarded), administration date: 25Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The patient received medication within 2 weeks of vaccination were hypothyroid med, thyroid med.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Oct2021 14:30, outcome "unknown", described as "Prev dose administration date: 25Apr2021/ Administration date: 02Oct2021"; FATIGUE (non-serious) with onset 01Oct2021 16:00, outcome "recovered" (04Oct2021), described as "Extreme fatigue"; HEADACHE (non-serious) with onset 01Oct2021 17:00, outcome "recovered" (05Oct2021), described as "Horrible headache"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2021 16:00, outcome "not recovered", described as "Pain at injection site"; PAIN (non-serious) with onset 03Oct2021 16:00, outcome "recovered" (05Oct2021), described as "Very Achy"; NAUSEA (non-serious) with onset 02Oct2021 16:00, outcome "not recovered", described as "Nausea"; LYMPHADENOPATHY (non-serious) with onset 03Oct2021 09:00, outcome "recovered" (11Oct2021), described as "Swollen Lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 01Oct2021, outcome "recovered" (04Oct2021), described as "Had sore left arm"; PAIN (non-serious), outcome "unknown", described as "Body aches". Therapeutic measures were not taken as a result of fatigue, headache, vaccination site pain, pain, nausea, lymphadenopathy, pain.  Additional information: Seriousness criteria was not Results in death, Life threatening Caused/prolonged hospitalization and Congenital anomaly/birth defect. Prior to vaccination, patient did 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 4 weeks prior to the COVID vaccine.After 2nd dose 01Oct2021 also had sore left arm for 3 days was nauseated 1st day fatigue started after a few hours lasted 3 days, very achy like non over started 03Oct2021 lasted 2 days.  No follow-up attempts are possible. No further information is expected.
1wk p/vax pt devel signs & sx c/w transverse myelitis, paresthesias & dysesthesia from T1 level down;sx have resolved somewhat since onset but not completely
Patient developed an unspecified hypersensitivity reaction; Information has been received from a physician via a company representative concerning to an adolescent male patient. No medical history, concurrent conditions nor concomitant medications were performed. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, lot number and expiration date not reported) for prophylaxis (reported as "adolescent patient"). On an unknown date, the patient experienced an unspecified hypersensitivity reaction (hypersensitivity). The patient sought medical attention. The outcome of hypersensitivity was unknown.       The relationship between hypersensitivity reaction and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Extreme tiredness and weakness.  Rested but still tired and weak as of Monday 10/11/21