chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). 17-Feb-2021, the patient experienced POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body) and ANXIETY (This is ruining my life). On an unknown date, the patient experienced GAIT DISTURBANCE (I cant walk). The patient was treated with DIGOXIN at an unspecified dose and frequency and ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) at an unspecified dose and frequency. On 17-Feb-2021 at 12:00 PM, ATRIAL FIBRILLATION (AFib) had not resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body), ANXIETY (This is ruining my life) and GAIT DISTURBANCE (I cant walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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. Further information has been requested.
Vomit on 06/04/10 and then on 06/05/2010 at 4:15 AM: Scream or squeal in pain, body spasm, bubbles from mouth, totally non-responsive, red (not blue) skin. Arms and Legs tightened as if severe muscle spasm or seizure.  Red rash (dots) on face, chest and arms.  Didnt make any sounds for several minutes-no crying or anything.
Swelling,redness,increased warmth, hardness at injection site, itching,burning
Red, swollen, hot to touch, localized reaction to right arm around injection site. Size about 6 inches in diameter. No fever.
Case number PHEH2012US025324 is an initial spontaneous report received from a nurse on 21 Dec 2012: This report refers to an 11-year-old male child. He was vaccinated with two doses of MENVEO (batch number: M11081) intramuscularly on 11 Dec 2012 and 20 Dec 2012. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
CC: arm swelling, flushing, skin redness; HPi: this is a 43 y/o female who presents to the UC with right arm swelling in area of injection site from COVID vaccination from 4/18/21. She had a faint shortness of breath but did not take albuterol. She has a history of multiple allergies and has been followed by an allergist. Husband noticed face was flushed this morning. Also general abdominal upset with diarrhea. No vomiting. No fever or chills. She reports often a delayed reaction to allergens. Gastrointestinal: Positive for abdominal distention and diarrhea. Skin: Positive for rash. All other systems reviewed and are negative. Medications, albuterol inhaler 4 puff (4 puffs Inhalation Given 4/26/21 1234), methylPREDNISolone sodium succcinate (PF) (SOLU-MEDROL) injectable 125 mg (125 mg Intravenous Given 4/26/21 1230), diphenhydrAMINE (BENADRYL) injectable 25 mg (25 mg Intravenous Given 4/26/21 1231), famotidine (PEPCID) 20 mg in NS 50 mL IV infusion (0 mg Intravenous Stopped 4/26/21 1251); Medical Decision Making: This is a 43 y/o female with history of multiple significant allergic reactions. Here with delayed allergic reaction to COVID vaccine. She was treated with Solumedrol 125mg IV benadryl 25mg IV and pepcid 20mg IV. The erythema of face and nec/shoulders resolved. She was also given albuterol inhaler. We discussed postponing the next covid vaccine until she confers with her allergist. Will treat with prednisone 50mg daily for 5 days, pepcid and benadryl.- Return precautions for recurrence of allergy or any other concerns. After careful consideration of patients presentation and clinical course, at this time there does not appear to be an indication for further emergent evaluation or intervention, nor is there an indication for admission to the hospital.  At the time of discharge I do not think, to the best of my medical judgment, that an emergent medical condition exists and patient is discharged home well-appearing in stable and satisfactory condition.  Discharge diagnosis, instructions and plan were discussed and understood.  Signs and symptoms that should prompt return to the Urgent Care were discussed and understood.  Both verbal and written discharge instructions were provided.  At the time of discharge patient appeared comfortable, was in no apparent distress and vital signs were within normal expected limits.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 29-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
Quarter-sized, Bullseye-like rash on right thigh.  Slight itch but not constant, only when sweaty after being outside. Used Hydrocortisone (no change), used max strength Lotrimin (no change) and was prescribed triamcinolone acetonide cream (no change). This lasted for little over four weeks, with no change until the end of the four week period. It began to dry up about six weeks since appearance only for a larger one to appear on the back of the thigh. Went back to doctor, advised to go to dermatologist (could not schedule apppintment) more showed up in the following weeks on my arms. Eventually disappeared mostly around mid-September. The first one scarred.
extreme fatigue requiring modification in activity, sleepyness, heaviness of lower extremities, injection site pain (moderate), pain left side of neck and scapular area
Client said she had pain in her left arm a few days after receiving the Hepatitis B vaccine in March. She said it got better, but she started getting more pain in the month of May. Client went to the ER on October 21, 2015 due to pain in her left arm because she had difficulty extending her left arm upward. Client's diagnosis from ER was "Myalgia".
Patient received the first dose of Polio 1/8/2020. Patient's father notified a rash on patient's head. back and stomach when giving him a bath that evening after patient received the shot. Patient's father  was notified to take patient to the ER for evaluation.
fever within several hours after receiving vaccine, temp of 101.3, pt was advised per his kidney dialysis dept to go to ER to have this addressed
My menstrual cycle began 2 weeks post  the vaccine (2nd COVID-19 dose). I have extremely regular cycles, and I had an extra one during this month.  Normal cycles resumed following the extra one.
Urticaria of trunk and extremities developed ~48 hours after vaccination.  Relatively mild with only intermittent pruritis. Pain and swelling of feet. Still present as of visit on 4/12/21. No other symptoms.
7/3/03: Red area on left thigh 8 x 6 cm non tender and non fluctuant. Tx:  Augmentin 400/5 tsp bid
Systemic: Generalized redness at site of injection. Not itchy or painful-Mild
Early evening post injection sore arm.  9 pm onset of chills, fever, continuing through night and following day.  Accompanied by severe fatigue, loss of appetite.  Treated with acetaminophen.  Fever and chills gone morning of 3/4, but severe fatigue persisted.  Morning of 3/5 feeling better, but lightheaded.  Improved throughout day and 3/5 evening pretty much back to normal.  No medical attention required.
After patient received the vaccine the following events occurred:  - Office visit with PCP 4/14/2021. Complaints consisted of chest pain, SOB, left shoulder and left breast soreness and pain, difficulty sleeping. CT and EKG test ordered and performed.  - CT result showed bilateral Pulmonary Embolism.  - Lower extremity doppler ultrasound was also performed and negative.  Patient is still admitted to hospital and awaiting overall outcome.
Respiratory distress with wheezing: patient treated with Albuteral nebulizer and Oral prednisone x 4 days
Pt vaccinated with DTP and IPV and developed two convulsions. Unspecified focal neurologic signs & could not cry. LP normal.
neuropathy type pain; cold sensation; pain and tingling on legs; pain and tingling on legs; unable to sleep; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy type pain"; FEELING COLD (non-serious), outcome "unknown", described as "cold sensation"; PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain and tingling on legs"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep". The events were evaluated at the physician office visit. Course of events: The patient got a cold sensation neuropathy type thing, pain and tingling on legs and being unable to sleep. Patient has been to 5 doctors about a side effect she had after the vaccine. The patient has been to a neurologist and rheumatologist about the neuropathy in her legs and they both feel it is from the vaccine. It has been 3 months for the patient and she has had lots of tingling and pain in her legs and can't sleep because of it. This all started right after the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
left upper arm redness, warmth, swelling beginning the night after vaccination,, extending down to left elbow area
SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Patient tolerated first round without adverse events. Second administration he had flu-like symptoms the evening of administration. Symptoms described as aches and pains, fever, chills, shivering, pain in arm. He describes considering going to ER that he felt so bad. Injection site was painful. Had vaccine administered at local pharmacy. Symptoms resolved in 24 hours and were self-limited.
Right deltoid red, swollen, heat present, raised 2mm circle deltoid about 10mm. Complained of itching last night.
On8-27-08,received DTap and IPV 2pm. 8-28-08 woke up with fever, T-101 gave tylenol.  8-30-2008 afebril, noon vomited x1 only. 8-31-2008 mom noticed hives,@ 4:30pm took him to IMC.  Dose 1 @ 5:45pm. Prelone 15/5 one tsp BID x 3 days, 1 tsp per day x 3 days, then 1/2 tsp per day x 3 days. Benedryl given midnight.  9-1-08 hives worse, seen in office 9-1-8 & 9-2-08. told hives may continue several weeks, recheck in office in 2 weeks if no improvement. Needs allergy referral prior to Td or Tdap.Also start Zytec instead of benedryl.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Rec'd shot 7/5, 3" red ring around area, dark red around shot entry. Feels like a golf ball inside. Very hard & sensitive to touch. Lots of heat felt also on raised area. Swollen 1 day after shot.
Narrative: 82yo male patient died on 11/28/2021 at non clinic from per notes "Acute respiratory failure with hypoxia (11/27/2021) Unknown septic shock 2/2 PNA Elevated D-dimer, cannot rule out PE". Pt had Hx of PMH: Chronic venous insufficiency Vitamin D deficiency Empty sella syndrome History of transurethral resection of prostate Benign Prostatic Hypertrophy With Outflo Prostate Cancer Bladder cancer History of bilateral cataract extraction Neurocognitive Disorder OA - Osteoarthritis History of recurrent urinary tract infec Retention of Urine, unspecified Hyperlipidemia Pt had received covid vaccines on 2/9/21 & 3/12/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
hives were all over her body; itching; became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat; Shingles; felt like it was burning; stinging; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer..  This case involves a 71 year old female patient who experienced shingles (herpes zoster), felt like it was burning (burning sensation), stinging (pain), hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat (blister), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   In 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2019, the patient developed a non-serious shingles (herpes zoster), felt like it was burning (burning sensation) and stinging (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  In 2020, the patient developed a non-serious hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat it was everywhere (blister) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reaction were mild.  It was also reported that while there were marks and now it is clear. No breathing difficulty noticed. It was basically a bad skin reaction. It was inside her groin and she was afraid it may go inside. She is currently seeing an Allergist too to assess what triggered the adverse event.  Details of laboratory data not reported.    Corrective treatment: Doctor prescribed her a topical steroid ointment and oral steroid tablets. Only thing that calmed her down was ice packs.  On an unknown date, the patient recovered from the all events (also reported that it lasted for 3 weeks and disappeared gradually).  There will be no information available on the batch number for this case.
Patient given COVID19-Moderna Bivalent 6-11 instead of the 2nd dose of the primary series that he needed.
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to  penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and  thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and  thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient has not been tested for COVID-19 since the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown dates, was vaccinated with an unspecified number of doses of GARDASIL (doses, routes and lot numbers not reported). The physician reported that on an unspecified date a Pap smear was performed and the result was a diagnosis of unspecified strains of high risk HPV's. At the time of the report, the patient's outcome was unknown. The relatedness for unspecified strains of high risk HPV's and GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
The patient states after the vaccine he experienced persistent soreness in the arm.  At ten days the soreness was still there.  He also states he has been experiencing migraine headaches.  These headaches are worse in the evening.
L upper arm pain - onset the evening of MMR injection, no redness. Tx'd with Naprosyn / Vicodin. Achy, deep arm pain persists 9/30/08
Dizziness, fulness in head, rapid breathing.  Client complained of dizziness, fullness of the head and rapid breathing.  Client assessed by onsite paramedic.  Vital signs assessed.  Client states feels much better, no further symptoms and previous symptoms resolved.  Client assessed for an additional 15 mins.  No further symptoms and client informed to, instructed to f/u with medical assistance should any further symptoms arise.
Nauseated; Vomited; Diarrhea; Headache; Body aches; Injection site pain; Fever of 102; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included eczema, asthma and seasonal allergy from an unknown date and patient had no known allergies. The past vaccination history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. There were no concomitant medications. The patient had not received any other vaccine and other medications with in four weeks and two weeks of vaccination. Patient had no COVID-19 prior to vaccination and was not tested for the same post vaccination. On 17Feb2021 patient woke up at 4:45 AM and experienced headache, body aches, injection site pain, nauseated, vomited, diarrhea, and a fever of 102 (usually 96, not 98). No treatment was provided as result of events and the outcome of the events was reported as not recovered.  Follow-up (25Feb-021): This is a follow-up spontaneous report received in response to the mail trail sent regarding confirmation of onset date of adverse events. A query response was received with respect to the event.
27NOV95 pt called & stated had broken out in a rash or hives w/in 1 hrs of vax;stated started to itch, skin was red & splotchy but not bumpy or pebbly like hives;took DPH the next day & rash went away;