chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with myeloma; This case was reported by a nurse via call center representative and described the occurrence of myeloma in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myeloma (serious criteria GSK medically significant). On an unknown date, the outcome of the myeloma was unknown.   It was unknown if the reporter considered the myeloma to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The nurse practitioner reported that a patient that received 1st dose of Shingrix and after that, was diagnosed with myeloma. The reporter consented to follow up.
Within 5 minutes post vax, the pt experienced a seizure. The pt was not treated but observed in the office. When released, the mother reported back to the office that a second seizure had occurred in the car on the way home. The pt has not had any further seizures and there has not been a further work-up since he recovered.
8/25/21 PMH of afib, HTN, AAA repair, pancreatitis, and acute cholangitis. General surgery being consulted for decreased output from his biliary drain and nausea.
After flu shot, start on Tuesday pt. started throwing up and severe diarrhea (poop out while throwing up) until today, living in a small town, has not seeing a doctor. She is getting PEPTO BISMOL, TUMS.  per her daughter 5:24pm.
Pediatric Patient received Pfizer Adult dose of 0.3ml instead of the 0.2ml child dose. Patient was contacted about an hour later of the incident and was feeling  fine. Advise about possible side effects was review with the patient's mother in case of a serious event.
Patient passed out right after injection and fell off bench he was sitting on.  Received a minor cut to his head and was going to go to urgent care to get it cleaned.
Outbreak of large, blistering, painful internal mouth lesions located upper and lower buccal tissue. The lesions were diagnosed by oral surgeon as atypical aphthous stomatitis.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health, per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Papulovesicular rases (scattered lesion) noted on 3/12/15 (10 days after immunization). Fever with rash and nasal congestion. Erythematous some time swelling at swelling of injection also noted on 3/11/15.
missed her period; This spontaneous case was reported by an other health care professional and describes the occurrence of AMENORRHOEA (missed her period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (missed her period). At the time of the report, AMENORRHOEA (missed her period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient reported that she is not sexually active and lab tests confirmed she is not pregnant. She know this is a potential side effect of the vaccine. Treatment information was not provided.   This case was linked to MOD-2022-604578 (Patient Link).
h/a, generalized aching, fever, malaise, no appetite, sl nausea; arms is sore @ inject site;
8/23/Patient developed rash. Awaiting Flu and Echo f/u10/6/10.
no additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) (strength and route were not reported; lot # U029147, expiration date: 16-MAR-2023) 0.5 milliliter for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 9 Fahrenheit (F)for a time frame of 1 hour and 25 minutes. There was no previous temperature excursions. No digital data logger was reported.  No additional adverse event (AE) information was provided.
Approx 15 lesions at various stages - few crusted lesions, others papules on erythematous
Arm is hurting, is really sore, can't even lift it - second dose; A little pain if she pushed on the area - first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is hurting, is really sore, can't even lift it - second dose) and VACCINATION SITE PAIN (A little pain if she pushed on the area - first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is hurting, is really sore, can't even lift it - second dose) and VACCINATION SITE PAIN (A little pain if she pushed on the area - first dose). At the time of the report, PAIN IN EXTREMITY (Arm is hurting, is really sore, can't even lift it - second dose) and VACCINATION SITE PAIN (A little pain if she pushed on the area - first dose) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 is not applicable
Right after the technician administered both vaccines the patient reported he felt woozy and tried to put his head in-between his arms.  Patient lost consciousness for about two to three seconds and regained consciousness on his own. When the patient lost consciousness, his body slid to the right side of the seat and the patient hit his head on the cabinet next to the chair. The patient did not fall onto the ground. 911 was called. Patient was monitored the entire time until EMS showed up. Patient denied any trouble breathing or swallowing or any pain. After the fact the patient told the pharmacy team that he normally passes out when he gets his blood drawn but he has never had a reaction or felt dizzy or fainted after a vaccine, so he did not mark that on his VAR form or mention anything ahead of time to the pharmacy team members. 911 was called a second time after they did not show up after about 15 minutes. Eventually about 45 to 60 minutes after the initial 911 call EMS showed up to the pharmacy. The patient was checked out by EMS. They checked his blood pressure and heart rate while sitting and standing, had his blood sugar checked and EMS manually checked the patient's head. EMS warned the patient about potential risks after passing out from a vaccine and from hitting his head. The patient declined transport to the emergency department. EMS recommended that the patient notify his doctor that his blood pressure was slightly elevated but not to the point that he needed to be transported immediately to the emergency room. The patient left on his own. The patient's healthcare provider office of  DO was notified on Monday, 10/23/2023. The nursing staff stated that they would reach out to the patient as follow up to see how he is doing.
Fine, dry rash; no redness or itching. No fever; feels fine. No other complaints. Rash is on face, neck, upper chest, arms and back.
Patient passed away unrelated to covid vaccine Narrative: The patient had end stage COPD and placed in hospice care. Patient received first dose of Moderna vaccine on 1/20 and second dose of Moderna vaccine on 2/16. No adverse reaction was reported. Patient passed away at home on 2/24/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Uncontrollable Shaking / Chills Fever Loss of appetite Nausea Violent throwing up Swelling of Left Arm from injection site to below elbow-hot to the touch. Fatigue  Spoke with Nurse at Clinic 10/16 but too ill to go there. Just starting to feel somewhat better 6 days later. Still Fatigued /weak
Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1243359) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (patient has allergy to erythromycin.), Seasonal allergy (patient feels sick to stomach certain latex bandages.), Blood pressure high and High cholesterol. Concomitant products included ATENOLOL, SIMVASTATIN (SIMVASTATIN +PHARMA) and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had taken unknown vaccine for Flu-ended up in emergency room within 5 hours of shot patient had taken Vitamin Apple cider vinegar capsules (2400 mg) as concomitant drug. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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
Pt. Was seen for covid-19 vaccination on 1/13/21. She presented to observation at 12:29pm for her 15 minute observation. Between 12:34-12:38pm pt. Endorsed sudden onset of dizziness and chills. I called for RN assistance who obtained VS and I began clinical assessment. Pt. Denied CP, SOB, DOE, difficulty swallowing was reported.  She was able to speak in full sentences, no audible wheezing, facial swelling, one sided weakness or difficulty with speech production. On exam: breath sounds clear, pt. diaphoretic, cool to touch, visible pallor. She denies prior allergic rxn to vaccinations, denies daily medication. Reports medical hx including Sjögren's syndrome and psoriasis. She reports eating breakfast (meal&juice) prior to vaccine administration. Denies allergies to food or medications.    12:40pm: BP 60/49, pulse 81, 02 sat 100%, RR 16. Repeat BP 60/33, rapid response (code blue) was called. Pt assisted transferred to clinical reclining chair, placed in supine reclining position, fluids started (500 bolus NS),FS glucose 93, and EMS called. Patient remained a&o x3, no syncope. 12:46-12:50pm: reported onset of stiffening of hands and l/e. below the knee. AROM remained intact in extremities.  Approximately 12:56pm EMS arrived, EKG WNL (per EMS), patient able to ambulate with assistance from reclining chair to EMS transport chair. Approximately 12:58pm BP 93/47. Pt. was stabilized in DTMO following 500 mL NS, BP 92/54 prior to departure to ED at 1:05pm.    RN contacted pt. Emergency contact (as documented in RN note) with EMS arrival and prior to  ED departure. Pt. Belongings were collected, including cellular phone, and placed in patient belonging bag and given to patient prior to her departure. RN will follow up with patient tomorrow and schedule in office follow up.  PCP notified per rapid response report.
Dose Administration Error (Invalid Dose); 4 doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered). At the time of the report, PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.     This case was linked to (E2B Linked Report).;crosslinked crosslinked
Patient accidently received too high a dose of the vaccine. The administrator withdrew 0.2mL of undiluted vaccine and added 1.3mL of diluent to the syringe. In total, the patient received 1.5mL of liquid with an estimated 28.5mcg of mRNA. At this time, there have been no reported reactions to this mistake.
This spontaneous report as received from a female patient of unknown age regarding herself. Patient's current condition included heart problems. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed a rash after receiving ZOSTAVAX. Patient sought medical attention for the same (saw the doctor). Patient underwent Routine blood work (results were not provided). No treatment was given. The outcome of developed a rash was reported as recovering/resolving. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 76 year old male patient with no drug reactions/allergies, who on 28-AUG-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously in the right arm (dose and lot # reported). Concomitant therapies included: atenolol 50 mg daily "Worphren" 1 mg; lisinopril (manufacturer unknown) 5 mg daily, and tamsulosin 0.4 mg daily. On 29-AUG-2013, the patient had a reaction to ZOSTAVAX. He was sore at the injection site on his right arm, and it was itchy. No treatment was given for the events. The outcome of the events was reported as recovering.  The relatedness of the events to therapy with ZOSTAVAX was not reported. The patient did not seek medical attention. Additional information has been requested.
Extreme soreness in left arm (as if punched very hard) that lasted for 4 days. Some fatigue and poor sleep for 2 days
extreme fatigue, fever of 101 for 70 hours, stomach pains from 9:00 Thursday morning to around 7:00 Sunday morning
PATIENT HAD RASH WITH ITCH ON LEFT ARM AND PATIENT WENT TO PCP ON 11/20/19. PCP DETERMINED PATIENT HAS SHINGLES.
Admission Date: 6/1/2022 Discharge Date: 06/03/2022  PRESENTING PROBLEM: AKI (acute kidney injury) (HCC) [N17.9] Acute kidney injury (HCC) [N17.9] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 81-year-old male who presented to the emergency department with chief complaint of generalized weakness and a fall.  In the emergency department, vital signs were stable.  Lab work was obtained and notable for acute kidney injury, leukocytosis and elevated troponin.  Patient was also positive for COVID-19.  CT head and CT C-spine were negative for acute abnormalities.  Chest x-ray was negative for acute cardiopulmonary disease.  Patient was admitted to the Internal Medicine Service for acute kidney injury on CKD 3. He was given IV fluids with improvement of his kidney function.  PT/OT evaluated the patient recommended home.  Acute kidney injury was likely prerenal secondary to poor oral intake in recent diarrhea from COVID-19.  Patient felt improved on discharge.  He has recommended follow-up this primary care physician and have a repeat BMP in 3-5 days.  He was discharged home in stable condition.
I contracted COVID a year after the vaccine. I do not believe it was because of the vaccine but I did want to document. I did have a fever, body aches, chills, cough, fatigue, and was sick to my stomach. COVID now went away, but my body is not the same. I get more winded, more tired, I have problems moving or eating that I did not have before.
developed a rash; Headache; Fatigue; Little bit of a fever; I did not receive the second dose; I got home and my ears were red, neck was red/Next morning entire trunk was red, skin right red; I had an allergic reaction an hour after the shot, no anaphylaxis or difficulty breathing only a skin reaction; From ears to trunk it looked like a second degree sun burn; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA MULTIFORME (I got home and my ears were red, neck was red/Next morning entire trunk was red, skin right red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LOSARTAN, ROSUVASTATIN and LEVOCETIRIZINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA MULTIFORME (I got home and my ears were red, neck was red/Next morning entire trunk was red, skin right red) (seriousness criterion medically significant), SKIN REACTION (I had an allergic reaction an hour after the shot, no anaphylaxis or difficulty breathing only a skin reaction), SUNBURN (From ears to trunk it looked like a second degree sun burn), PAIN (Body ache), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Little bit of a fever) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose). On 25-Feb-2021, the patient experienced RASH (developed a rash). On 24-Feb-2021, PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) had resolved. On 01-Mar-2021, ERYTHEMA MULTIFORME (I got home and my ears were red, neck was red/Next morning entire trunk was red, skin right red), SKIN REACTION (I had an allergic reaction an hour after the shot, no anaphylaxis or difficulty breathing only a skin reaction), SUNBURN (From ears to trunk it looked like a second degree sun burn), PAIN (Body ache), RASH (developed a rash), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Little bit of a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by reporter.
Large swollen area over the elbow down from site of injection, very hard and warm to touch, pt reported severe pain and immobility of arm for a couple days.
Felt like electrical current through brain from ear to ear, heard different pitches in ear (varied from ear to ear and time to time.  Lost appetite and lost weigh (30 lbs). Got the booster (10/30/2021, IM, LA, Lot #  FF8841 ) After booster, pressure behind left eye, centralized migraine headache above left eye in left temple, sinus infections, off balance. Hunger headaches due to not eating.  Certain foods do taste different or worse. Diagnosed with Mariner's Disease.
Sporadic urticaria flare-ups, triggered by skin contact when it included friction or pressure (friction of towel while drying after shower, pressure of shoulder bag strap on shoulder). Ongoing for 6 weeks so far. Symptoms suppressed by loratidine 10 mg/d.
pt recvd vax;pt devel under 50 varicella like lesions & rash on back & chest; no fever; MD reported on 20jul95 pt broke out in a few scattered chicken pox;
20APR99 1:45 pt recv vax & c/o h/a immed p/vax monitored closely x 15min;2Pm cont c/o h/a APAP given;210PM c/o tingling & numbness of extremities, queasiness, dyspnea & chest heaviness;911 called;
a real bad rash that was not severe, just red, sore, and irritating; a real bad rash that was not severe, just red, sore, and irritating; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that after first dose,  3-4 days after she got a real bad rash that was not severe, just red, sore, and irritating. It started coming slowly. Rash was located on her neck. The patient was unsure if the rash was from the vaccine.  The patient thought, maybe she put too much chemical on her hair/head. Clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Second dose was received 4:00 PM friday, June 25.  Symptoms started next morning, June 26 at 8:00am.  Experienced migraine, nausea, diarrhea, chills, fatigue, stomach cramps and lasted about 14 hours.  Followed by fatigue the next day.
8 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old). On 07-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No Concomitant medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non-Significant follow up appended: reporter added