chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full broad celiac reaction; got collapsed at living room; took 1 hour to reach her bedroom; upset stomach; dizziness; cannot go for work whole week; headache; nausea; body ache; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (full broad celiac reaction) and LOSS OF CONSCIOUSNESS (got collapsed at living room) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Celiac disease and Gluten sensitivity.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced COELIAC DISEASE (full broad celiac reaction) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (got collapsed at living room) (seriousness criterion medically significant), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, COELIAC DISEASE (full broad celiac reaction), LOSS OF CONSCIOUSNESS (got collapsed at living room), GAIT DISTURBANCE (took 1 hour to reach her bedroom), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), IMPAIRED WORK ABILITY (cannot go for work whole week), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported events started within 5 minutes of receiving the vaccine. She  talked to her pharmacist first regarding the symptoms and also contacted her health care provider but a nurse told her these are all common side effects and recommended she go to the emergency room. The consumer denied to go to the emergency room.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's concurrent medical conditions of Celiac disease remains a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's concurrent medical conditions of Celiac disease remains a confounder.
Sore arm Fatigue  Hoarse voice Headache  Muscle ache Cloudy head
Right neck and shoulder pain that has increasingly worsened and now pain all the way down the arm with numbness and tingling.  To see primary care physician tomorrow.
Patient presented to the ED and was subsequently hospitalized for respiratory distress, history of squamous cell carcinoma  within 6 weeks of receiving COVID vaccination.
Discharge Provider: MD Primary Care Physician at Discharge:  DO  Admission Date: 5/26/2022  PRESENTING PROBLEM: Hyperbilirubinemia [E80.6] Elevated liver enzymes [R74.8] Acute on chronic combined systolic and diastolic CHF (congestive heart failure) (HCC) [I50.43] Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22] COVID [U07.1]   HOSPITAL COURSE: Patient is a 71-year-old male with a past medical history significant for recent COVID-19 infection status post treatment and completion of dexamethasone, oxygen-dependent chronic obstructive pulmonary disease, coronary artery disease, chronic systolic and diastolic heart failure who presented with difficulty breathing well as hypoxia.  He is usually on 2 L of oxygen via nasal cannula.  In the emergency department he was found to be hypoxic with sats 72 on 2 L and VBG showed pH of 7.24 with CO2 of 59. He was initially placed on non-rebreather and then placed on BiPAP. He has persistent atrial fibrillation which is rate controlled with metoprolol and amiodarone and is also on Xarelto. Patient  felt to to have chronic combined hypoxic and hypercarbic respiratory failure due to CHF exacerbation and chronic obstructive pulmonary disease exacerbation.  There was also concern that he had pneumonia due to infiltrates as well as leukocytosis.  Patient was placed on vancomycin and Zosyn.  MRSA screen came back negative and therefore vancomycin was discontinued.  He was rapidly weaned off BiPAP and placed on 6 L of oxygen via nasal cannula. Patient's home torsemide was held and he was placed on IV Lasix.  Cardiology was consulted who agreed with IV diuresis.  Patient had improvement of his symptoms.  Leukocytosis did improve. Blood cultures did not reveal any growth. He was initially placed on Solu-Medrol and then transitioned to prednisone.   Patient had very little improvement in his symptoms with IV Lasix.  He also had increase in his creatinine and therefore Nephrology was consulted.  Nephrology place patient on Lasix infusion but he still did not have adequate diuresis.   Patient's condition declined acutely the morning of 5/31 and he became increasingly short of breath with increased work of breathing.  Prior to this he was a full code and when code status was discussed previously, patient stated that he did not wish to change it.  However as his condition declined, patient stated that he wished to become a do not resuscitate.  His condition declined even further and he was made comfort care late afternoon 5/31.  Hospice was consulted and patient was made inpatient hospice.
Within 24 hr of vax, pt devel urticaria at site of Acel-Immune & upper left arm. Pt recovered p/36 hr.
Patient was working  and fell on the job due to what was perceived to be a seizure. Paramedics were called, and patient was taken to the emergency room. Initial reports from the hospital are that patient has clotting in the arm around the injection site. Patient is still at the hospital at the time of this report.
Pt recv vax on 11/4/98; on same day pt exp itchy arms w/ red, raised bumps, itchy back & legs; pt tx for scabies
Left arm 6 months later still stuck,  ears ringing. Tinnitus now very bad; Left arm 6 months later still stuck,  ears ringing. Tinnitus now very bad; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration, administered in left arm on 12Mar2021 07:00, at 70 years of age, (Batch/Lot Number: Ew0150) as single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included estrogens conjugated (PREMARIN) taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that on 12Mar2021 08:00 she experienced left arm stuck, ears ringing, tinnitus. These events were assessed serious as disabling/incapacitating. On 31Aug2021 the patient underwent SARS-CoV-2 test (nasal swab) which was negative. It was reported that 6 months later the left arm was still stuck, ears were still ringing and tinnitus was now very bad. No treatment was administered for the events. At the time of the report the event had not resolved yet.  Follow-up attempts are completed. No further information is expected.
Reaction to sticker/adhesive on skin. Only has happened after vaccine, even from bandaid
No additional AE reported; Nurse calling to report that an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant therapies were not provided.  On 22-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe 0.5mL, lot# S010729, expiration date 01-DEC-2021 (frequency, route of administration, and anatomical location were not provided), as prophylaxis (Expired product administered). The reported also confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) was reported.
Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 35-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.
Td vaccine received on 8/15. Had some swelling and pain at site; reduced slowly after a few weeks. Still had some pain. Continues not all the time; when lifts something or turns head in certain way; still feels it. Intensity reducing gradually. When using muscle where injection performed, feels pain.
accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     Information regarding relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD. HCP mentioned 2 doses were given on 19-FEB-2023, 1 dose on 20-FEB-2023, and 1 dose on 10-MAR-2023. Caller did not specified which date corresponded to patient 2. HCP stated patient 2 did not reported any AEs.   No treatment medications was reported.  This case contains information about patient-2 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-715321, US-MODERNATX, INC.-MOD-2023-715348, US-MODERNATX, INC.-MOD-2023-715347 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715321:Patient 4 case US-MODERNATX, INC.-MOD-2023-715348:Patient 3 case US-MODERNATX, INC.-MOD-2023-715347:Patient 1 case
30 to 45 minutes after shot arm pain at site radiating to elbow, wrist and shoulder of left arm lasting 3 days. Followed by fatigue, headache and tightness of chest starting on the 12th. Fatigue, headache and tightness of chest worst on the 15th accompanied by dizziness and chest pain BP elevated 10 point over normal to 140/90s, pulse and O2 fine. Side affects lessened on the 16th to tightness in chest and reduced headache and subsided by the 17th.
Patient had COVID exposure 4/4/2021.  On 4/11/2021 developed rhinorrhea.  COVID PCR positive.
Dosing error ( 2nd dose schedule beyond the recommended interval); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 011J20) with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 011J20) with no associated AEs.
Left arm pain for 7 days; Swelling to tricep; no redness, slight warmth to touch, to the bicep area
Pt recvd vax & 4 days later exp arthralgia joints, fatigue, conjunctivitis, x 2 wks & serum sickness; abn CXR revealed an adenopathy; p/initial report dated cont w/severe sx of fatigue, muscle & joint pain, cough & SOB; 25MAY93 bronchoscopy
I have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine; It can't move my head that hurts it is excruciating pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Aug2021 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. Medical history included osteoarthritis from an unknown date and unknown if ongoing, bipolar from an unknown date and unknown if ongoing. Patient had concomitant medication (patient stated, "Yes" (Further clarification unknown)). Patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Jul2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient experienced as, i have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine, it can't move my head that hurts it is excruciating pain on 14Aug2021. Reporter stated, It was the Pfizer Covid-19 Vaccine, the second dose. Patient had both shot. Patient got the shot last night and when he woke up in morning he have a real bad pain in his neck at the bottom by his shoulder on the same side of the vaccine. It ca not move my head that hurts it was excruciating pain. Event start date: patient stated "14Aug2021(Confirmed as 14Aug2021) less than 24 hours later". No treatment were received for the events (Consumer stated, "For my pain, no"). Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approx 35 hours post vaccine I broke out in about 7 or so hives on both my right and left legs.  I have never in my 35 years prior ever had hives before.  I am treating with Benadryl and a topical cream.  They have still not gone away.
Side effect unknown; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect unknown) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect unknown). At the time of the report, ADVERSE EVENT (Side effect unknown) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: OutcomeTCS document attached
Within 24 hours, pt's mother noticed arm was red and by 1pm next day, left arm was swollen, red and hot to the touch. On 05/16/2002, arm was back to normal. No medication given.
Patient was given 0.5 ml instead of 0.25mg booster vaccine 3rd dosage, and patient was called on 1/19/2022 and denies any problems since vaccination. A letter was sent to patient informing of dosage given.
Dizziness, flush/hot about 3.5-4 hours after Hep B vaccine. BP 114/80, R 14, P 78; RRR Lungs: clear. No rash, no itching.
Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; This is a spontaneous report from a contactable other HCP. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 20Dec2020 17:30 at a single dose for covid-19 immunisation. The vaccine was administered in the hospital. Medical history included asthma. The patient was not diagnosed COVID-91 prior to vaccination. There were no concomitant medications. On 20Dec2020 21:00, the patient experienced severe diarrhea for 3-4 hours starting 2 hours after vaccine, fatigue for several days and headache. The outcome of the events was recovered on an unknown date. No treatment was required for the events. The patient was not tested for covid-19 post vaccination.  Information about lot/ batch number has been requested.
Localized reaction with erythema, warmth, and mild tenderness which started one week after administration of vaccination.
Dizzy; Loss of appetite; Headache; Fever; Hot and cold chills; Tender lump in armpit; Body aches; Lack of focus; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 05May2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient was allergic to onion (food allergy). The patient has taken amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Concomitant medication included fluoxetine (MANUFACTURER UNKNOWN) once daily, started on an unknown start date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 14Apr2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 00:00, the patient experienced dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue. The adverse events did not result in a visit to doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of these events. The clinical outcome of the events dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
I have not had my period,  should have come on the 11th-13th.  I?m always regular, and not sexuality active.  I have some mild pms symptoms .  Also reduced sex drive.
It was reported that a 10-year-old male patient received a TD Adult vaccination on 5/22/01 at 3:30pm. Reportedly within a few hours the patient developed sever arm pain and swelling. Treatment of Benadryl and cold compresses to the injection site was advised.
Dizziness, Headache, Light headed, blurred peripheral vision; slight disequilibrium Narrative:  approx 2 hours after vaccine was feeling light headed/dizzy and felt as though her peripheral vision was blurred, also had a HA- made better with Tylenol. 98.4-110/81-67-99% O2. Observed standing/walking - slight unsteady on feet/disequilibrium
day of vax pt was cranky & acted ill;next day 24hr later went unconscious for 8hr;pt brain swelled;pt died;
Patient had previously well controlled seizures with his medication regimen and vagal nerve stimulator (VNS) implant.  Within 48 hrs after first dose, patient started to experience increased seizure frequency. Patient has had to increase antiepileptic medications and adjustments had to be made to VNS device to obtain seizure control again,.
Patient developed a blotchy, hive like, red rash over much of the body which was noticed about 3 hours post vaccination once patient's clothes were off for a diaper change. The rash covered the back, stomach,  both thigh areas (including the thigh where the shot was), and armpits. Immediately post vaccination (during the post vaccination waiting period) the patient behaved happily but I (father) noticed a few bumps under his thighs that I presumed were diaper rash. Only when I returned home did I realize they were much more prolific all over his body. Given that there were no noted issues with breathing, scratching at the rash, or any behavioral change, we decided to watch and monitor.  The next day we called the pediatrician who advised  us that a rash isn't uncommon but to monitor for issues with breathing, scratching, or behavior change.   The rash continued for 5 more days before progressively fading.  During the course of this we treated him with Diphenhydramine  Liquid 12.5 mg/ 5 milliliters (mL)  with a dose of 2.5 ml, once or twice daily. The medicine did not seem to improve nor worsen condition.  I'd like to emphasize that the patient's behavior was normal throughout this, but the fact that the rash was so widespread created cause for concern, since in adults "COVID Arm" appears to be much more limited to the injection site itself. It was also hard to distinguish the initial rash / hives from a larger allergic reaction at first.