chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having an issue with my ears. I felt like I was under water.; I also started having twitching in my left cheek, in the cheek bone area.; I felt like I was under water.; I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating; This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.), FEELING ABNORMAL (I felt like I was under water.) and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Cipro) and Penicillin allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.), FEELING ABNORMAL (I felt like I was under water.) and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) in February 2021 at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.) and FEELING ABNORMAL (I felt like I was under water.) had not resolved and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating) had resolved.            Concomitant medication details were not reported. Patient felt like patient was under water. It would sometimes be in 1 ear, sometimes both.Patient took Claritin & it clears it up. It goes away as fast as it came. Patient started having twitching in left cheek, in the cheek bone area. It comes & goes, but it's not a Bells Palsy. Patient saw PCP, stated patient's ears were fine. Patient denied that patient ever had COVID positive test or diagnosis.. Event Sore arm and Twitching facial did not cause the patient to seek medical care. Event Ear discomfort and Feeling abnormal cause patient to seek medical care. Patient had not experienced event Twitching facial in the past.
Immediately after receiving Moderna vaccine, pt started wheezing and reported trouble breathing. Pt said her throat wasn't closing up, but stated she felt short of breath and burning in her lungs. Due to wheezing, gave pt two 25mg benadryl tablets and bottle of water. Pt sat in IMZ room for about 10 minutes during which I checked on her multiple times and she seemed to be improving after a couple minutes. Pt was able to move to sit in chair outside of pharmacy for an additional 20 minutes after which she left the store feeling fine.
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV on an unknown date. the subject received Flu Seasonal QIV at week 5 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. The relationship of the vaccine exposure during pregnancy to treatment with Flu Seasonal QIV was not reported. Additional details provided: The due date is April 2015. No other AEs were reported, the caller did not know the patient's date of birth.
Patient with subjective itching without visible hives. Zyrtec 10mg PO was given. With serial monitoring, the patient returned to baseline. He was discharged home as his own driver, no drowsiness noted.
Arm started to itch a little and then swell up at the injection site with warmth, redness and arm pain. It initially lasted 5-6 days and the arm pain and redness lessened and now 8-9 days later it swelled up bigger, redder. More painful and itchy.
right arm pain and numbness, right ulnar neuropathy, blood clot in the eye, fibromyalgia, low back pain
Aches and weakness began 12 hrs after shot. Up all night with chills, super hot to touch skin (but low fever), and nausea. Couldn?t sleep much and woke up with same but worse symptoms
Five blood clots in my lungs.  Symptons are shortness of breath.  Treatment is blood thinners for 6 months.
Patient received Pfizer vaccines on 1/28/21 and 2/18/21, tested positive for COVID by PCR on 7/9/21. Admitted to hospital due to dyspnea on exertion on 7/9/21 and diagnosed w/ presumed COVID-19 pneumonia, received remdesivir. Patient has underlying h/o of relapsed CLL and lives in an assisted living community.
cried for 2 hrs slept cried for 2 more hrs p/last crying episode had a staring eye appearance for 30-45mins;
Immunization (KINRIX) given on 5/12/2009; mom noticed and reported localized swelling of L arm on 5/14/09, arm swollen to twice the normal size from elbow to shoulder, warm to touch, pinkish - red in color, pain to touch but no impaired ROM; received no localized or systemic treatment.
temperature 102 Chills Headache Upset stomach tired rash on injection arms that was swollen and hot
Redness and swelling around the area the vaccine was given. Arm also feels warm to the touch.
Approximately 4 inch area of pink tissue at site of injection. Darker red area (approx. -> 2 inches) in the middle of pink skin. Warm, swollen at site of injection. Appears to be 2 small blisters within red area of skin.
Diagnosed with Iron Deficiency Anemia.  Over the past yr Hgb 14 dropped to Hgb 8.  Symptoms include: Malaise, extreme Fatigue, dizziness, fainting,  HAIR LOSS, Headaches, Shortness of Breath, restless leg syndrom... and Pale skin with full body Skin Lesions... Chest pain, Arrhythmias, palpitations, white pale and cold hands and feet  Treatment, IV INFED. 6hr infusion x 3 so far... will continue to assess with hematologist.
Arm soreness; Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and EXPOSURE VIA BREAST MILK (Breast feeding) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension. Concurrent medical conditions included Alcohol use (occasionally). Concomitant products included NATURE MADE MULTI PRENATAL from 09-Jan-2019 to an unknown date for Breast feeding, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness) and EXPOSURE VIA BREAST MILK (Breast feeding). On 27-Dec-2020, PAIN IN EXTREMITY (Arm soreness) had resolved and EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she was exclusively breast feeding her 10 month old baby who was born on 09-09-2020 (4 weeks early, 34 weeks+ 2days f gestation). No associated adverse events reported.   This case was linked to MOD-2020-001985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: F/U-1 : VAERS, Dose 2 Vaccination date, Date of Birth; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs.  Patient will continue to be contacted for further monitoring of AEs
8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?.  Symptoms lasted 4 days . Then intermittent fever & chills .  After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !)  . Extreme fatigue for a week .
Heart flutter; Tightness in neck; Hard time Breathing; Excessive sweating; Local swelling; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever). At the time of the report, CARDIAC FLUTTER (Heart flutter), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment information was not provided. It was reported that symptoms were better during the day, some symptoms worsen again while relaxing 8/4.  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.
repeat titer in July and was still not immune to rubeola; received  MMR II on 3/31/2023 and 5/1/2023. Caller stated repeat titer in July and was still not immune to rubeola; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient was not immune to rubeola based on a titer. The patient's concurrent conditions and concomitant medications were not provided.   Since the patient did not had documentation of the original vaccination series, she received 2 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus vaccine, Live (M-M-R II) on 31-MAR-2023 (Product administered to patient of inappropriate age) and 01-MAY-2023 (doses, frequency, routes and anatomical locations of administration, lot numbers and expiration dates were not provided) administered as prophylaxis.  The patient then had a repeat titer in July of 2023 and was still not immune to rubeola (Vaccination failure, Measles antibody negative). The patient sought medical attention while working with school wellness center. The outcome of vaccination failure and Measles antibody negative was not provided.  The causal relationship of the vaccine was assessed as related to vaccination failure. Causal relationship between the vaccine and Measles antibody negative was not provided.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Controlled hypertension and High cholesterol (controlled). Concomitant products included PREDNISONE and HYDROCORTISONE for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product included Blood Pressure Medication, Cholesterol Medicine and Medication for prostrate. Patient received first booster dose sometime in the fall of 2021. Patient experienced sore injection site arm for first, second and first booster dose. No treatment information was provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-639221 (E2B Linked Report). This case was linked to MOD-2022-638954 (Patient Link).; Sender's Comments: MODERNATX, INC.-MOD-2022-639221: Same reporter
Pt came back into clinic as soon as she left, tightness in her chest, pressure, throat felt like it was closing, she was able to swallow 25 mg Benadryl, PO 1:34  BP110/50, p 83, sats 98% 1 :44 BP 120/70 P 84 Sats 99.% 2:05 BP 110/60 P 78 Sats 99% @:07, Heart rate went up to 155, second dose of25 mg Benedryl PO.  2:15 BP 110/68, P 73 Sats 99. She walked out to the car, her mother was to take her up tp Primary MD, 1mile away. She is encouraged to follow up with us.
Tingling, numbness in the hands, feet, and face. "Pins and needles" feeling.
swelling, redness, tenderness at site of shot.   Red face and warm forehead, no thermometer to check but believe slightly elevated temp. Later, circa 9AM, face redness and warm disappeared.  Otherwise feels good.
redness, itching & swelling appeared the AM;sx progressively worsened;large red, hard, tightly swollen area from mid deltoid 140mm towards antecubital space, reddened skin cont another 80mm beyond swelling;very extensive local rxn;
Muscle and bone aches all over the body, chills, sweats, lasting 5-6 hours. Headache.
pain from head to the back; blurred vision; I'm in pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain). At the time of the report, BACK PAIN (pain from head to the back), VISION BLURRED (blurred vision) and PAIN (I'm in pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vein in her right ankle and it started to hurt; ankle on her right side started swelling; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on arm left on 26Feb2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiry date: 30Jun2021) on left arm on 05Feb2021 for covid-19 immunisation. The patient experienced blood clot in her right ankle, varicose vein in her right ankle and it started to hurt, ankle on her right side started swelling, all on an unknown date. All events caused patient physician office visit. Treatment received for all events. It is reported that she is calling about the Covid 19 vaccine. She wanted to report that she developed a blood clot in her right ankle. She went to the doctor yesterday on 06Apr2021. She would like to add she has no prior history of any type of blood issues. The doctor she saw thought that the blood clot and the Covid 19 vaccine could be related but would not commit to saying so directly. She started having issues about 6 days after the second Covid 19 vaccine. She doesn't exactly remember when, maybe the 04Mar2021 or 05Mar2021. She ignored the issues attributing them to over exercising. She reached a point where she couldn't ignore the issues anymore and went to the doctor. Caller clarifies she has a varicose vein in her right ankle and it started to hurt then her ankle on her right side started swelling. She only payed attention to her ankle when it got worse. The last 3 weeks have been awful. She would like it known that she does not lead a sedimentary lifestyle. She rides her bike 60 miles a week and walks 10 miles a week. She's always moving. This is unusual for her. The doctor she saw diagnosed her with a blood clot and he did a sonogram in his office. She has been prescribed Xarelto 15mg tablets. Take 2 tablets twice daily for the first 21 days then on the 22nd day start taking one 20mg tablet once daily. The patient underwent lab tests and procedures which included sonogram: unknown result on 06Apr2021. The outcome of the all events was unknown.
Facial droop. Bells palsy Famciclovir 750 mg TID x 7 days predisone 60mg PO x 7 days, Neurontin 300 mg x 10 days.  11/25/08 Reviewed PCP medical records of 10/29-11/5/2008. FINAL DX: Bell's palsy Records reveal patient experienced right facial droop, HA, shooting pain in throat. Exam noted droop of right mouth & eyelid, decreased smile on right.  Tx w/antiviral & steroids & neurontin for pain.
The patient is a 95 y/o female with hx of DMII, HTN, hyponatremia (?SIADH as on salt tabs TID,) hypothyroidism who presented to the ED with cough and SOB. Patient is a poor historian. Patient reports she has had a cough and SOB for the past 2 days. She denies any chest pain. Per review of her chart which was sent, she tested positive for COVID on 1/12. It appears she was given a prescription for Augmentin on 1/4 for a 10 day course with diagnosis listed as pleural effusion. She was also started on Lasix 40 mg po qd on 1/12. She has no known diagnosis of CHF as far as I can tell. On 1/17 there is an order for oxygen at 2L. Discussed with patient's healthcare proxy via telephone who reports.  patient has been ill for about 10 days and did complete a course of antibiotics. She reports the patient was moved to the COVID ward 2 days ago at (Privacy) and she thinks this may be why she continues to say she has been ill for 2 days. She denies any history of dementia in the patient and reports she is normally quite sharp. Today the patient was transferred to our ED for worsening SOB and hypoxia with O2 sat of 77% on 3L. She was placed on 100% NRB by EMS en route with O2 sat reportedly 90%. Of note, patient has a diagnosis of dysphagia on records from (Privacy). I was initially told she has received COVID-19 vaccine x 2 + booster, but in her records I only find two doses of COVID-19 vaccine, in May and June 2021. In the ED, patient is noted to be hemodynamically stable. She has been placed on 12L O2 with O2 sat mid 90s. Laboratory studies are significant for BUN 33, creatinine 1.7 (unknown baseline, last Cr 1.6 in February, before that normal,) Pro-BNP 8574, troponin 147. ABG reveals pH 7.39, pCO2 52, pO2 103 on 15L NC. Patient was decreased to 10L with repeat pO2 of 66 and was then turned back up to 12L. CXR reveals chronic markings with predominantly right sided airspace disease and small right pleural effusion. Case was discussed with on-call Cardiology who did not feel Heparin infusion was necessary for elevated troponin. Hospitalist service is asked for admission.   Of note, HCP document from the (Privacy) is outdated. Most recent DPOA is scanned in under Advanced Directive/Living Will and names (Privacy) and (Privacy) as patient's healthcare proxies.  PT IS CURRENTLY INPATIENT.
This spontaneous report was received from a physician refers to a 70 year old female patient. On an unknown date in the year 2011 (also reported as about three years ago), the patient was vaccinated with ZOSTAVAX. On 28-JAN-2014, the patient experienced shingles. On 28-JAN-2014, the patient sought medical attention and was seen by the patient. The outcome of the event shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Follow-up information received from the reporting physician indicated that the patient recovered. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old male patient who experienced fever and diffuse erythematous rash. At 2 months of age, the patient received the first dose on 15-May-2006. The patient also received the first dose of Act-Hib, the first dose of Rotateq and the first dose of Pediarix on 15-May-2006. On 15-May-2006, the patient developed fever which had resolved. On 18-May-2006, the patient experienced a diffuse erythematous rash. The patient recovered on an unknown date.
"expired" dose of the Pfizer COVID Vaccine this AM; drawn up in the syringe beyond 6 hours per caller; drawn up in the syringe beyond 6 hours per caller; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown, Expiration Date: 23Sep2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Sep2021, outcome "unknown", described as ""expired" dose of the Pfizer COVID Vaccine this AM"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 27Sep2021, outcome "unknown" and all described as "drawn up in the syringe beyond 6 hours per caller".  Additional information: The vaccine was expired after having been drawn up in the syringe beyond 6 hours per caller. Total time in syringes: up to 24 hours at 2 degree C to 30 degree C with no more than 6 hours at room temperature (up to 30 degree C) and the remainder in the refrigerator (2 degree C to 8 degree C).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt presents to ED with worsening SOB; pt states he's had trouble with pneumonia over the past month and has been on multiple ABX; was seen at an urgent care a few days ago, was tested for COVID but unsure of the results; pt found to be positive for COVID in ED; hypoxic with O2 sats in low 80s%; O2 supplementation; baricitinib and dexamethasone; pt's respiratory status worsened; status changed to DNR/DNI; pt desaturates with minimal exertion; pt continued to worsen and he passed away in the hospital