chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad reaction to the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (bad reaction to the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 VACCINATION SITE REACTION (bad reaction to the first dose).            This case was linked to MOD-2021-034320 (Patient Link).   Reporter did not allow further contact
My ankles swelled up a day later on March 7th nd they are still swelled up now both ankles and up into my calves. Skin is so tight. Have had the following done on April 12th - Heart test along with Kidney and Liver test which were all good. Also had a blood test and for 73 years old I hd a perfect blood test with cholesterol number at 150 and my HDH and LDL and triglycerides were all 2 to 3 times better than recommended. 12-weeks later my ankles and calves are still swelled up. On May 25th I had an Ultra Sound on both legs from the groin down and it came back with NO blood clots.
Asthma got worse; Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg; Lower back pain; Terrible pain just to put feet on the floor / pain never went away; Hurt so much she was badly crying in pain every day; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day), ASTHMA (Asthma got worse) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028ACCA and 040AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE and SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg). On an unknown date, the patient experienced ASTHMA (Asthma got worse). At the time of the report, BACK PAIN (Lower back pain), PAIN (Terrible pain just to put feet on the floor / pain never went away), CRYING (Hurt so much she was badly crying in pain every day) and ARTHRALGIA (Joint pain so severe that she can't walk/ now in the house and it still hurts/ joint pain in hip and knee,  right ankle and leg) had not resolved and ASTHMA (Asthma got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, X-ray: normal (normal) nothing is in her knee.         Treatment includes steroid shot at two different times.  Patient initially went back to work, but it hurt so much she was badly crying in pain every day and had to quit job after working there for five years. Patient went to urgent care in June. Though patient asthma got aggravated she used her usual medications only.   This case was linked to MOD-2021-358732 (Patient Link).
During routine flu immunization, felt a sharp pain at the injection site and a sensation as if something was being forced into my arm. Subsequently and to this day, I've had pain in my shoulder and difficulty moving/lifting my arm.  Pain level and difficulty moving was highest upon waking in the morning. I had difficulty dressing/undressing and performing other daily tasks. Pain level/difficulty moving showed no improvement until about 20 November, when it began to improve but still has not cleared up completely. There was no redness, swelling, or lumps at the site. In my lifetime (I am 48), I have never experienced pain or other complications from an immunization that persisted more than two days.
Narrative: COVID infection following COVID vaccine series 01/05, Pfizer, dose #1 01/27, Pfizer, dose #2 08/24 pt cc: No symptoms exposure: unknown 08/24 CTA PE impression: Bilateral pneumonia. Viral pneumonia is within the differential. No pulmonary embolus. 08/24 CXR impression: Bilateral lung opacities most consistent with multifocal pneumonia including atypical/viral pneumonia. Follow-up to resolution after appropriate treatment recommended. 08/24 COVID swab, result: detected 08/2 pt admit to Medicine cc: shortness of breath & fever dx: Bilateral Pneumonia / Covid-19 (+) Acute Hypoxemic respiratory failure LOS: 5 days 08/24 PROCALCITONIN result: 0.27 08/24 DDIMER result: 11.61 08/24 ferritin result: 1295.6 08/24 LACTC ACID result: 0.83 08/24 ABG result: i-pH 7.51, i-PCO2 39.0, i-PO2 50, i-HCO3 30.9 08/24 COVID-19 ANTIGEN (BINAX) result: not detected 08/24 IRON SATURATION 21.07 08/24 FERRITIN result: 1299.7 08/24 TRANSFERRIN result: 98 08/24 IRON result: 29 08/24 TSH result: 0.489 08/24 ESR result: 30 08/25 Fibrinogen result: 749 08/25 DDIMER result: 7.05 08/26 ESR result 65 08/26 Fibrinogen result: 459 08/26 DDIMER result: 4.99 08/26 INR result: 1.35 08/26 PT result: 15.1 08/27 ESR result: 37 08/27 Fibrinogen result: 353 08/27 DDIMER result: 4.72 08/28 Fibrinogen result: 391 08/28 DDIMER result: 5.42 08/28 ESR result: 43 08/29 Fibrinogen result: 336 08/29 DDIMER result: 2.44 08/29 ESR result: 18 08/30 ESR 30 08/30 Fibrinogen result: 353 08/30 DDIMER result: 2.02 09/18 CXR result: Improved aeration of the lungs compared to the recent prior studies, but with significant persistent airspace and interstitial opacities suggestive of area of scarring and fibrosis. Persistent or recurrent pneumonia cannot be excluded. Continued attention on follow-up examination is recommended. 09/20 FERRITIN result: 205.4
Client woke up this morning with lightheadedness, dizziness, syncopal episode, followed by shaking and nausea and vomiting.
One day post vax, pt developed an injection site reaction characterized by extreme swelling and a purpuric rash. The pt was seen by the physician on 7/12/99. No further information was available at the date of this report.
Severe rheumatoid arthritis flare (in hands) (swelling of knuckles, extreme pain, curling of hands into a "claw"). Required cortisone shot to calm flare (successfully).
C/o horrible HA & nausea & vomiting 2 hours after injection. Still with nausea.
78 y.o. male patient with history of UTIs, T2DM, paroxysmal atrial fibrillation, DVT, PAD, HTN, urinary incontinence, depression and anxiety who presented with anxiety and fever, found to have respiratory failure, COVID-19, severe sepsis and acute ESBL UTI. He was treated with steroids and was weaned off of O2 prior to discharge. He was treated with Ertapenem for 3 days until urine culture returned with typical E. Coli s/t Bactrim (same as before) and ID recommended that he finish 14 total days of Bactrim.    Acute hypoxic respiratory failure -- resovled COVID-19 Virus Infection Date of onset of symptoms: 7 days prior to admission Symptoms present on admission: nausea, fever, diarrhea, cough Date of covid positive test: 11/29 Vaccination status: vaccinated CXR (reviewed personally): No acute pulmonary findings CTPA: No evidence of PE or acute pulmonary abnormality Oxygen requirements on admission: 3-4L NC in ED Current oxygen requirements: RA Medical therapy: steroids x10d, out of window for remdesivir (already took Paxlovid) Consultants following: Infectious Disease Anticipated special isolation end date: 12/8/22   Severe Sepsis, POA -- resolved Urinary Tract Infection Hx of ESBL E. Coli Hx of Pyelonephritis Patient febrile (101.8), tachypneic, with leukocytosis on admission Likely sources include UTI and COVID-19 pneumonia LA 4.4 on admission UA positive nitrite, large leukocyte esterase, 122 WBCs, >180 RBCs, many bacteria Blood cultures pending, urine cultures with ESBL E. Coli ID consulted -- PO Bactrim through 12/10   Type 2 Diabetes, Insulin Dependent A1c of 8.7 on 10/24/22 Home regimen 30u lantus nightly with SSI Continued on admission   Urinary Incontinence Likely due to radiation after prostate cancer treatment Follows with doctor Home solifenacin 10mg daily  Paroxysmal Atrial Fibrillation EKG with NSR Continue home BB and restart apixaban (especially in light of COVID infection) Pt will f/u with doctor to discuss further   Peripheral Arterial Disease Hx of DVT Continue home lipitor, plavix Restarted apixaban as above   HTN Continue home lisinopril, hydrochlorothiazide, toprol   Anxiety/Depression Continue home buspar, cymbalta, ativan PRN
He had his first vaccine for the Pfizer (lot 3013DBA?the D is either a D of an O) Covid 9/24/21. He is required by his work to get another form. He has had sweating, abdominal pain, and headaches since then. He feels ?off.? The abdominal pain was like a ?twist? from his umbilicus to his diaphragm that lasted three hours and resolved. Since then he has had 2-3 bowel movements a day. The sweating is profuse. This is getting less frequent.  The headaches are fight-frontal. They are stable?he did not get them before this?and now he gets two a day. He did not have a fever. Symptoms were first noted about four hours after the vaccine.  The patient?s symptom severity is rated as: ?8.?
low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
SOB Narrative: Patient contacted telephone triage nurse today requesting advice. Pt is c/o SOB with activity x 2 week, gradually worsening. States no SOB at rest, "But every time I do anything exertive at all, I get short winded." States SOB is acc by chest tightness, which usually lasts approximately 10 minutes then spontaneously resolved. Some intermittent radiation to left arm during SOB episodes. Patient states he feels fine right no, "as long as I'm just sitting in a chair, I am fine - so that's what I've been doing the past 2 days." Has had no dizziness, SOB or chest pain today, last event occurred 2 days ago. Recommended local ER now. States he will have family member driver him to ER now.
patient received first dose of MODERNA. As soon as the immunization was complete, he started feeling faint. I called a pharmacy technician into the room with me, and got him a water. He slumped in the chair, fainted, as his head fell back  he made a groaning noise, eyes rolled. I went into get the radio to call code white and when I returned he had come to, and was asking to lay on the floor. He was sweating and clammy. The optical manager, helped me and pharmacy technician get him to the floor. He did not want an ambulance because he was starting to feel better. After 15 minutes of water and cold pack on his neck, he was recovered. He was talking and up walking. He left with his brother and brother's girlfriend.
4 days later had a real diminishment in sense of smells; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ANOSMIA (4 days later had a real diminishment in sense of smells) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Recovered within 2-3 days) in January 2021. Concomitant products included ALFUZOSIN and DOXYCYCLINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (4 days later had a real diminishment in sense of smells). At the time of the report, ANOSMIA (4 days later had a real diminishment in sense of smells) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included steroid for 12 days   This case was linked to MOD-2021-132540 (Patient Link).
She developed a varicella-type rash to her torso and left jawline 13 days after the Varivax injection. No other symptoms.
Vaccine expired on 9/26. It was not pulled from inventory. Pt was down, so this allowed the nurse to pull the expired vaccine. If Pt was up and running we would not have picked that lot number as it would not be available to select in the system because it is automatically taken out.
Patient claims she cannot move her arm freely after receiving the vaccine.  The arm still hurts and is getting worse each day. There was no redness/swelling at the site of injection
Joint stiffness and myalgias throughout body. Diaphorisis over night and in morning.
Two months after receiving my second dose, I was diagnosed with bladder cancer. I had noticed urine in my blood and I contacted my PCP. She did a urine test and everything came back normal. She referred me to a neurologist and they put a scope in my bladder and saw the tumor. They scheduled surgery for me in May, where they went into the bladder and removed the tumor and took tissue samples around the tumor. The results came back that it was cancer. I went back a couple of weeks later and they checked my bladder again to make sure they removed all of the cancer. I now get a vaccine put into my bladder to prevent any cancer from coming back. I've had five treatments so far. This will go on for three years if the results come back negative each time. I will go back to the surgery center in October and they will check my bladder again to make sure the cancer has not returned. I have gone and received the third vaccine now.
Local swelling distal to vaccine 5 wide x8cm long, blotchy and warm, not painful, is itchy, no fever. Local reaction. Note: only child allergic to is pesto.
Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) via an unspecified route of administration in the left arm on 11Jan2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies to peanuts. Concomitant medications were not reported. The patient previously had known allergies to amoxicillin. The patient experienced burn and itching throughout the entire body on 11Jan2021 which resulted to emergency room/department or urgent care. Treatment for the events included Benadryl. The patient had no COVID prior to vaccination. He did not have COVID tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovering.
had the flu; fever; chills; headache; vomiting; diarrhea; so sick felt like I was dying out of work for a week; Initial information regarding an unsolicited valid non-serious social media case was received from a consumer (patient) on 08-Dec-2020.  This case involved patient with unknown demographics who had the flu (Influenza), fever (Pyrexia), chills, headache, vomiting, diarrhea and Illness (so sick felt like was dying out of work for a week), while he/she received vaccine Influenza Vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date about 10:30 am, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu (Influenza), fever (Pyrexia), chills, headache, vomiting, diarrhea and Illness (so sick felt like was dying out of work for a week) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the events, at the time of reporting.  There will be no information available on the batch number for this case.
crackling sensation in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (crackling sensation in right ear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VALPROATE SEMISODIUM (DEPAKOTE), ATORVASTATIN, IRON, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and MELATONIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (crackling sensation in right ear). At the time of the report, TINNITUS (crackling sensation in right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated about 30 minutes later she started to get crackling sensation in right ear.  Treatment information was not reported.
Did not receive the full dose; A spontaneous report was received from a health care professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive full dose/accidental underdose.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, during administration of the Moderna COVID-19 vaccine, the nurse pulled the needle out of the patient's arm too quickly and the patient did not receive the full dose of the vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, did not receive full dose/accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: not provided) with no associated AEs.
After 2nd shot, fainted at 3am due to low blood pressure, outcome paramedics came, doctor said probably could be vaccine component side affect. Chest pain, Electrocardiography outcome was fine, continue to have chest pain. Tinnitus left ear got referred from my primary care doctor to ENT specialist. Prescribed Lipo Flavonoid 2x a day for one month. Folllow up appointment 10/29/2021 no change, continue to have tinnitus.
lump on right side of cheek. pus filled and painful. injected an antibiotic to treat said lump.
My body just felt bad and did not feel well for 10 days, and anxiety was incipient , with the second shot  four days later it felt like an anxiety attack on steroids, and left me with annoying tinnitus in left ear. Tinnitus and anxiety continues , and not feeling well, painful rash on arm that received the shot on second dose, which cleared up, and painful headache for 24 hrs, various aches and pains
Vision interference, tachycardia, hypertension, flush, rash, sweaty, hot, shakey, light headedness
This spontaneous report as received from a nurse refers to a  12 month old patient, of unknown gender . Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 20-MAR-2019 , the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780  and expiration date 01-JUL-2020 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccine was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases.; Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011572: US-009507513-1903USA011573: US-009507513-1903USA011574: US-009507513-1903USA011570:
PT experienced fever, chills, and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extrimities set in.  PT was medevac'd to Hospital and spent 2 days in the hospital DX with vasculitis.  Released 29 Nov 11 Fit for Full Duty Asymptomatic.
After receiving a vaccination, on 10/07/1999, the patient experienced persistent proximal shoulder and thigh pain similar to polymyalgia rheumatica. The patient was responsive to Prednisone greater than or equal to 10mg every day, but normal erythrocyte sedimentation rate 2 wks after the vaccination.
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu.  Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication.  I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
pt. recvd, 1st dose of Hep B vax & later devel induration & tenderness @ inject site which persisted 7-10 days.
8/04 - Received MMR, VZV and Hep A. 8/14 - Mom noted rashes on neck, behind ears and chest and eventually progressing to abd. and legs in 3-4 days. Fever (-). 8/19 - Rashes cleared up.
Information has been received from a physician concerning a 12-year-old female who "11 years ago" in approximately 1996, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 22-OCT-2007, the patient sought medical attention and was diagnosed with wild-type chickenpox. The number of lesions is not known but the physician stated that she was "covered from head to feet". At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
1. Syncopal episode with chest tightness and wheeze. Epinephrine 0.3 mg, Albuterol Nebulizer 0.5 mg