chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within first 2 hrs extreme fatigue, chills, migraine and a lot of body pain. Slight stomach ache, Lasted over 24hrs.
Admitted for abnormal ekg, dizziness, presyncope,  ongoing disorientation, dyspnea, tachycardia, vocal chords not meeting, chronic Severe muscle pain, heat intolerance,  Weakness, orthostatic intolerance, hyPeradrenergic POTS syndrome, unspecified autoimmune syndrome, parasthesias, possible mast cell activation, cerebral hypo perfusion, nausea,  patients uses walker or cane , throat pain, myalgia,  developed apnea, gasping while sleeping, very low to high heart rate while sleeping, hoarseness, inability to vocalize well at times
14 cm X 8 cm area on left thigh of induration on 08/22/2002, warmth. Patchy erythema area at lower border only on 08/23/2002-No warmth, No tenderness on exam, No fever, PO every six hours 1/2 tsp x 1-2 days.
Rashes under the breast/rashes in the inner thighs/3rd of her whole body had rashes; Hives around the injection site; rashes and hives around the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Rashes under the breast/rashes in the inner thighs/3rd of her whole body had rashes), VACCINATION SITE URTICARIA (Hives around the injection site) and VACCINATION SITE RASH (rashes and hives around the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced RASH (Rashes under the breast/rashes in the inner thighs/3rd of her whole body had rashes), VACCINATION SITE URTICARIA (Hives around the injection site) and VACCINATION SITE RASH (rashes and hives around the injection site). At the time of the report, RASH (Rashes under the breast/rashes in the inner thighs/3rd of her whole body had rashes), VACCINATION SITE URTICARIA (Hives around the injection site) and VACCINATION SITE RASH (rashes and hives around the injection site) 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 was reported for the events.
Upon receiving the vaccine, I immediately fainted (vasovagal syncope). I was unconscious for ~15-20 seconds. My apartment-mate who came with me for the shot laid me down on the floor until I could sit up again without feeling dizzy (~15 min). I also had pretty serious bruising at the injection site for ~9 days following the injection and my arm was swollen and painful (although this is a pretty normal side-effect).
Dizziness at first, but went ago within 10 min. Same day in afternoon, having symptoms  like when you are on the airplane, your ears get plugged and you have to blow out. I noticed since i never have this problem before. Until today, 12/30/2020, i still have this problem.  Today, 12/30/2020, i waked up with bad headache ( again, i don't have HA for years) then started having some chills (house kept warm at 74 F). Took tylenol 500mg x1.  As reporting, still have HA and ear problem. No chill.
Muscle pain at injection site, chills, feverish, malaise, mild headache, woozy/slight dizziness, weakness.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
A report has been received from a Health Professional concerning, male subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 15-DEC-2014. Reporter stated that we inadvertently administered expired FLUMIST Quadrivalent to two patients. Patient have not reported any adverse effects on 15-DEC-2014. The outcome of the event of inadvertently expired FLUMIST Quadrivalent to two patients is unknown. The report was considered to be non-serious.
A pharmacist reported that a pt received the vaccine on 10/6/99 and subsequently developed an injection site reaction characterized by redness, warmth, discomfort and a burning sensation during the injection. The pt could "actually feel the medication spreading after it was given." The pt recovered within 24 hours. The reported indicated that 10 pt's experienced this event, however they are not presently identifiable. Additional reports will be generated when information is provided. This is 1 of 2 reports from this facility of adverse experiences following the receipt of Flu Shield lot number 4998257.
Case number PHEH2012US000902, is an initial spontaneous report received from consumer on 06 Jan 2012 with the following internal review done on 07 Apr 2012 of data received on 06 Jan 2012. This report refers to 24-years-old adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 03 Jan 2012. On 04 Jan 2012, she felt achy, chills and developed headache. On 05 Jan 2012, the injection site was warm to touch, swollen and painful. On 06 Jan 2012, her neck became sore and stiff. The outcome of the events reported as ongoing. The causality of the events was not reported. Following internal review on 07 Apr 2012 of data received on 06 Jan 2012, the following correction had been done: Changed the labeling of pain (she felt achy) from listed to unlisted.
Starting at about 5pm on the day of vaccination, I experienced intense but expected side effects including full body muscle ache, fever, drowsiness, cold sweats, joint pain. These symptoms lasted for about 24hrs before subsiding completely by that Tuesday evening. On Thursday, 5/13, I woke up with moderate tightness in my chest that progressed over the course of 45 minutes to be severe chest pain. At that point, my wife drove me to the ER in  where I was checked in at about 8:30am. By the time I was checked in the chest pain had subsided to be just a slight discomfort, overall the chest pain had lasted for approximately 2 hours. At the ER my bloodwork was done and the initial blood samples returned an elevated Troponin I level of 5.04 ng/ml. While at the ER at the  I experienced one more incident of chest pain which lasted roughly 30 minutes and was moderately low on the pain scale. I was given multiple EKGs, X-rays, and Echocardiograms, all of which showed no abnormalities. Repeated troponin tests however showed an increase in my levels over the course of the day from 5 up to 12.6 and 13. I was placed on a heparin drip in the afternoon. By doctor recommendation I was air-lifted to later that night at 10:30pm so that further scans and a possible cardiac catheterization and CT scans. The following day, Friday, at 1am at my bloodwork was taken and troponin levels had increased to 14. I was scheduled for a CT scan, cardiac MRI, and echocardiogram to confirm the diagnosis of Myocarditis. By Saturday afternoon I was taken off of the heparin drip and told that they would not be able to perform any of the scheduled tests until Monday at the earliest. My most recent troponin level came back as a 9. At this point I decided to check myself out of  against medical advice since they were not able to run the necessary scans and my wife and I do not live in . I returned home to and followed up on 5/19 with a doctor at the ER at  since I was unable to find any available appointments with any cardiologists in the area for the next few weeks. My troponin levels and EKG taken at came back as normal, so I continue to follow doctor advice of bedrest and no alcohol for the next 4-6 weeks. My pulse is still elevated (roughly 85 bpm resting when it used to be at <65 bpm resting) and seems to easily increase with even moderate activity such as walking in the house up to over 100 bpm.
hands and shoulder were tender, sore; His hands swelled; The fingers are stiff; painful/ hand pain/sore; bilateral shoulder pain / sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore) in a 96-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCIN [PNEUMOCOCCAL VACCINE] (Pneumococcal conjugate PCV20) on 01-Dec-2020 and Janssen (0.5 ml) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Janssen and PNEUMOCIN [PNEUMOCOCCAL VACCINE]. Concurrent medical conditions included Drug allergy (codeine (reaction: rash, itching)), Hypothyroidism and Hearing loss.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Feb-2023, the patient experienced TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of one time and MELOXICAM at an unspecified dose and frequency. At the time of the report, TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dosage text was reported as Initial booster.  The caregiver was advised to give the patient Benadryl, but that just made patient sleepy and wasn't helping, so she stopped it. The caregiver had said the shoulders aren't swollen, but the hands are swollen. They went into the emergency room on Tuesday 21-Mar-2023, and that provider was the one who notified the pharmacist. The pharmacist states that 24-Mar-2023 patient notes state: bilateral shoulder and hand pain, swelling in hand. They had been applying heat to the hands with some relief. The veteran feels run down. Patient did not report redness or swelling at the injection site. No other aggravating or alleviating factors. It hasn't changed at all over the past month.
I began My menstrual cycle  and I was not due to begin my menstrual cycle four days after I received my initial dose. When I begin my cycle, it was out of the ordinary heavy and it lasted for approximately two weeks. This is out of the ordinary and typically my periods are not heavy and are not long. I no longer get periods as I take birth control continuously every month and so it is odd for me to get my period For a long amount of time and heavy at that.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 15-APR-2017 for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately April 2017 [reported as within 30 days of receiving ZOSTAVAX], the patient developed and was diagnosed with facial paralysis. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, facial paralysis was determined to be medically significant. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster, and facial paralysis were considered to be disabling. Additional information has been requested.
pt recv vax & devel a rash & exp SOB; No further details were provided;
Inject site swollen, extending R arm. Inner upper arm bruised looking. Was told not to receive vax again by Ask a Nurse.
fatigue, myalgias, fever, cough, loose stools, decreased appetite, coughing, short of breath
fatigue, chills started about 8 hours after the vaccine;  went to bed early and by 24 hrs the reactions had gone away. No pain at the injection site.
Pulmonary embolism; This case was split from master case 202201157463 to capture a patient received BNT162B2 and experienced pulmonary embolism.  This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".  Clinical Course: Information was received from a physician concerning a patient, who received Suspect product apixaban for Pulmonary embolism (5 milligram(s) 2 every 1 Day), lot number: Unknown. On an unknown date, the patient experienced arthralgia (knee pain) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of apixaban medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for event arthralgia to product apixaban. Tracking of Changes: 08-Sep-2022: Initial information was received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
patient was last in the presence of a family member on Saturday (unspecified date) who two days later developed chills and fever and was diagnosed with the virus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient was given the COVID vaccine at work on an unspecified date and was due to take part two of the vaccine on Monday (unspecified date). However, it was reported that patient was last in the presence of a family member on Saturday (unspecified date) who two days later developed chills and fever and was diagnosed with the virus. Patient stated, "So, like I said two days after I left visiting this family member they developed it. I have no symptoms do I still take the vaccine on Monday as I am due to take it, part two of the vaccine?" Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Excruciating episodic right flank pain occurring every 10 minutes and lasting 5-15 seconds over 48 hours like I was getting stabbed with a hot knife or poker;  This was followed by 7-10 days of intermittent, fleeting neuralgic pain over my right posterior iliac crest area occurring every 5-30 minutes.  This seems to have resolved over the past 5 days. This was after my first Moderna vaccine.  Supposed to receive the second on May 5,2021
Pressure in chest at 24 hours afterwards lasting 5 minutes, again 10 days later lasting 10 minutes then 11 days after lasting longer and went to the ER. EKG test good, heart enzyme (troponin) tests showed slightly increasing damage over the first 6 hours, then decreasing. chest X-Ray, Lexiscan, heart Cath and stent in the MLAD on 4/3/21.
16MAR92 pt recvd DTP/OPV/MMR/HIB a/noon; 8PM pt was exp difficulty breathing; had a prev dx of asthma, taken to local ER; not responding to tx for astham; later life-flighted to hosp x 3 days; 17MAR92 WBC 32,000; dx pneumonia;
The patient was vaccinated Friday 3/9/18. That evening she complained of chills, aches, soreness and a red colored reaction at the site of injection (approximately 3 inches in diameter). She stated that most symptoms improved by Saturday evening 3/10/18. Today 3/12/18 she still has the red arm rash and will see her physician.
flu symptoms; pain in the arm; This is a spontaneous report received from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced pain in the arm on 27Feb2021 with outcome of unknown , flu symptoms on 28Feb2021 with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Patient was sitting in waiting area after receiving first dose of COVID19 vaccine. She began to feel like she might pass out. Patient was laid on the floor. Other symptoms reported included hot and sweaty and nauseous. Patient was observed in the waiting area for longer until she felt better.
Child became pale, diaphoretic and tachycardic, had a syncopal episode
pain across the back and shoulders; pain across the back and shoulders; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire). On an unknown date, the patient experienced BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders). At the time of the report, PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was pale and sweating a few minutes following administration of the vaccine. After having water and staying seated for a few minutes, the symptoms reversed and patient stated feeling better.
Positive ANA ab test result indicating autoimmune; Positive ANA ab test result indicating autoimmune; AST=224; ALT=492; Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 12Apr2021 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number: EP6955,, Pev dose lot number: False), administration date: 22Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), ANTINUCLEAR ANTIBODY POSITIVE (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Positive ANA ab test result indicating autoimmune"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "AST=224"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "ALT=492"; HEPATIC ENZYME INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224". The events "ast=224", "alt=492" and "patient went to doctor for possible uti, which was negative, follow up tests has been having increasing liver enzyme test since jun. most recent alt=492;ast=224" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (01Jun2021) 492; antinuclear antibody: (04Dec2021) positive, notes: indicating autoimmune; aspartate aminotransferase: (01Jun2021) 224; hepatic enzyme: (01Jun2021) increasing; investigation: (01Jun2021) negative; sars-cov-2 test: (2021) unknown result, notes: COVID test type: Post vaccination: Blood test. Therapeutic measures were not taken as a result of autoimmune disorder, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, antinuclear antibody positive.  No follow-up attempts are possible. No further information is expected.