chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed sore throat approximately 6 hours after receiving injection and throughout next few days developed body aches and headache. Approximately 4-5 days later, reports fever, ear ache, coughing, runny nose, headache, body ache, and fatique. Reports unable to work during this time.  Did not take temperature with thermometer.  Did not seek medical testing or care.  Reports symptoms resolved after 2 weeks and has returned to work.
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On 23-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (0.5 ml dose, intramuscular injection, lot # 0420AE that was expired at the time of administration, the expiration date was reported as 01-DEC-2014. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for contact was given.
Very nervous before vaccine. About 7 mins after the vaccine felt S&S of panic attack. Heart racing, chest tighness, dizziness
Two days after administration she developed a 5-8 inch red mark and her arm was warm, swollen & sore to touch. After 1 week it changed to a triangle red/puffy ~4 inch area. 10-11 days after, started to feel better, redness is starting to clear.
Pt experienced a 104F fever for 4 days.  When the fever resolved pt developed a rash a the injection site the size of a quarter. Pt also developed a rash on his chest.  The rash on his chest resolved but there was still a ring on his leg. Approximately 1 month post vax pt developed a new rash on his head, back, stomach and on the back of his neck.
fever of 101F; body aches; sore throat; runny nose; cough; This case was reported by a nurse via call center representative and described the occurrence of fever in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number NA23N, expiry date unknown) for prophylaxis.   On 5th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 5th October 2020, 8 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced fever, general body pain, sore throat, runny nose and cough. On an unknown date, the outcome of the fever, general body pain, sore throat, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, sore throat, runny nose and cough to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received a dose of Fluarix and 8 hours later the patient developed a fever of 101 degree Fahrenheit, body aches, sore throat, runny nose and then eventually a cough. The patient tested for COVID twice and was negative. The patient said that runny nose, sore throat and fever had resolved, mostly in her chest till the time of reporting. The reporter consented to follow up.
pt completed Engerix-B series in JUN90; 19JUL90 no antibodies detected p/2 series;
Not feeling very well; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was not feeling very well.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date in 2021, after the administration of vaccine, the patient was not feeling very well.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, not feeling very well was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
We conducted a one day clinic for COVID-19 pfizer vaccine.  Workers were asked verbally once they walked in if they had had a COVID vaccine before and were also informed that we had the Pfizer vaccine available today.  Consent forms and pre-vaccination checklist were given to everyone that was getting the vaccine.  Pt. told us verbally that he has not had a COVID-19 vaccine and also filled out the consent and questionnaire telling us he had not had a COVID vaccine. Our system had internet  interruptions and we were not able to verify prior to administering the vaccine..  We discovered this information a few minutes after we regained access and tried to enter information into immtrac.  We left a detailed message with pt. encouraging him to report to VAERS as he was not truthful on his consents and requested a call back.  We apologize for any inconveniences.
The most adverse symptom was that my right leg swelled up and did not go away. I went to my doctor's office and they diagnosed blood clot by doing an ultrasound On Wednesday October 12, 2022. I was prescribed the blood thinner Eloquis, advised to modify my diet and get plenty of rest. I have since got worse and developed a new symptom where I could not put any weight on my leg and my knee swelled. I went to the doctor who sent me to the emergency room. The did several blood test and x-rays and drained the fluid out of my knee. I was diagnosed with Gout. I was prescribed Allopurinol and Colchicine and released after 10 hours. I went to work yesterday but woke up today swollen again and was not able to go to work. I have 2 follow ups at the end of the month. One is for an orthopedic doctor for my ankle as it is also swollen. It was an old injury that flared up pretty bad with everything else.
approximately 5 minutes after vaccine, pt began with a constant cough and tightness in her chest, no airway swelling.  Evaluated by allergist on site given cetirizine and albuterol 2 puffs with good effect monitored for 45 minutes, evaluated the patient on 1/2/21. Patient's symptoms resolved after 10minutes. Complete Progress note from chart below. -HD, MSO "Patient here for 30min vaccine clinic visit dose #1. She has a hx of asthma and contrast, NSAID allergy. 10min after dose patient complained of throat Discomfort and coughing that felt like her asthma sxs.  Coughing extensively on exam but NAD. Uvular exam normal, no flushing, no rash, resp: no wheezing, no rales or ronchi. Given 10mg cetirzine, albuterol 2puffs inhaler x 1. Sxs resolved in 10min, observed for full 30min time frame and sent home. Prior to next vaccine recommend 10mg cetirizine 20min before and 2 puffs of albuterol 20min before dosing.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 15:10 (Lot number: EN6208) at the age of 82 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Lump" (unspecified if ongoing); "Surgery" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN (ongoing); ALPRAZOLAM taken for anxiety, start date: 2012 (ongoing); ATORVASTATIN (ongoing); CARVEDILOL; THYROID (ongoing); CITALOPRAM (ongoing); CENTRUM SILVER [ASCORBIC ACID; BETACAROTENE; BIOTIN; CALCIUM; CHROMIUM; COLECALCIFEROL; COPPER; FOLIC ACID; IODINE; IRON; LYCOPENE; MAGNESIUM; MANGANESE; NICOTINAMIDE; PANTOTHENIC ACID; PHOSPHORUS; PHYTOMENADIONE; POTASSIUM; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN; FOCUS FACTOR; TURMERIC [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (1st dose, Lot number: EN6201, Vaccine location: Left arm), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Stiff neck"; NECK PAIN (non-serious), outcome "not recovered", described as "Neck ache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes". Additional information: The events did not require a visit to physician or ER. Iron pill was also included in the patient's concomitant medications. No follow-up attempts are possible. No further information is expected.
Vertigo, muscle aches, chills, headaches, nausea, hot flashes, fatigue, tinnisitis
Information has been received from the mother of a 22 year old hospitalized female with sickle cell anemia and no allergies who on 4/8/2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, for sickle cell anemia. Concomitant therapy included dexamethasone (manufacturer unknown) and acetaminophen oxycodone hydrochloride (Percocet). It was noted that the patient was hospitalized for her sickle cell anemia. On 4/8/2006 she was released after receiving the pneumococcal 23v polysaccharide vaccine. On 4/8/2006, at bed time, the patient experienced fever, soreness and tiredness. On 4/9/2006 the patient was again hospitalized. At the time of the report, the patient was hospitalized and considered to be not recovered. Additional information has been requested. 5/11/06 Received hospital medical records which reveal patient was hospitalized 4/5/06 w/dx sickle cell crises, hypokalemia & leukocytosis.  Hematologist found patient to have severe & symptomatic vaso-occlusive crisis, jaundice, fever & leukocytosis.  Received pneumovax prior to d/c on 4/8/06.  Readmitted on 4/9/06 w/recurrent sickle cell crises.  CXR 4/13 revealed RLL consolidation & cardiomegaly.  Thoracic US revealed right side pleural effusion vs empyema.  Cardiologist noted +S4.  Chest tube inserted RLL.  ID consult done.  CXR revealed diffuse bilateral interstitial infiltrate.  Dx made of acute chest syndrome & patient received exchange transfusion to which she responded very well but CXR showed RLL consolidation & dx w/pulmonary infarct.  Received IV antibiotics & partially resolved.  D/C home 4/20/06./ss
10 minutes following injection,  feeling hot and flush, nausea.  Instructed by nurse at clinic to take benedryl.   i stunted to remain at site additional time, mild improvement of symptoms by time permitted to leave. Symptoms returned intermittently throughout the day, and included headache and chest palpitations.    Resting HR 110 to 120 bpm.  Treated with additional doses of benedryl, tylenol,  and Ibuprofen.  Persisted for over 24 hours.  Throughout night also developed vomiting,  sinus congestion, sorethroat, chills, and intense body aches.  Contacted PCP office and instructed to continue with OTC treatments and rest.
Arm pain [ left arm injection ] on 8/22. Continued sensitivity and sensory issues exist (today 9/19). These extend down the arm into the forearm.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 11-JUL-2017, the patient was vaccinated with an expired dose of VAQTA (strength: 50/1.0 U/ml, lot # M022556 with expiry date 26-MAY-2017) intramuscularly for prophylaxis (dose and anatomical location not reported). No adverse effect was reported. No additional information was provided. Additional information has been requested.
Site: Itching at Injection Site-Mild, Additional Details: Patient presented with a paper stating Varicella. Patient was given shingrix which is approved for adults 18 plus who are immunocomprimed or at high risk for shingles(varicella zoster). Patient came back a week later stating they actually needed varicella for chickenpox(varivax). Pharmacist pulled up an article that supports shingrix can be accepted as a dose for chickenpox and provided it to the patient.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, LOSARTAN, DEXLANSOPRAZOLE (DEXILANT), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOLTERODINE TARTRATE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest). At the time of the report, PRURITUS (itching on left palm of hand) and URTICARIA (hives on thighs, butt, and lower chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The next day after shot I was very dizzy. Fell on floor going to bathroom. Ears and nose appeared stuffed up. I have only been out of bed 2 days since getting this shot 3 weeks ago. I have tried decongestants, Meclizine for dizziness., Levofloxacin and azithromycin for possible sinus infection..
Fever of 103 - onset 3/16/06 low grade - 3/17/06 fever 102-103- Seen CMHS - Rash 3/18 and 3/19 fever continue > 102 - Rash onset 3/18-
Woke up around 2 a.m. on 1/26/21 with a temp of 102.3 and took Ibruprofen, then again 101.8 on 1/26/21 p.m. and took Ibuprofen again.  Then at 3 a.m. on 1/27/21 woke up with burning on right inner thigh to discover a red, inflamed areas on both thighs, top of feet and upper lateral breast areas bilaterally, and left upper forearm including the injection site.  Rash is also on right hip area.  Non itchy rash, but had some inital burning on her right thigh.  Developed achiness & fatigue on 1/26.  Treated with OTC Iburprofen and Benadryl.
irregular heart rhythm; heaviness feeling in neck; swollen lymph nodes in left neck and breast since my first dose; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 21Jun2021 (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient was no known allergies. Concomitant medications included amitriptyline, received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021, the patient had not felt right since vaccine, which clarified that patient had swollen lymph nodes in left neck and breast since her first dose. The patient had been very fatigue and also have been experiencing a heaviness feeling in neck ever since as well. The patient have noticed a irregular heart rhythm too. The adverse events resulted in [Doctor or other healthcare professional office/clinic visit]. The patient did not received treatment for the events. The outcome of the events was reported as not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Arrythmia cannot be completely excluded.The case will be reassessed if additional information becomes available. 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.
MInor received 2nd dose by mistake and 1 dose was recevied on 8.9.23
Heart is fluttering; High Blood Pressure 191/115 mmHg; Palpitation; Insomnia; Not sure if he is having Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Blood pressure measurement: high (High) 191/115 mmHg. On 11-Jan-2022, Heart rate: high (High) 95 BPM.         Reporter stated that patient did not have side effects after the first 2 doses.  Patient medical history totally healthy, Never had heart or blood pressure Issues. He never had COVID-Disease and he never had a positive PCR test.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dizziness and heart palpitations/elevated blood pressure 20 minutes after injection. Redness and warmth in ears and face about an hour after injection, but this subsided after another 15-20 minutes. Temperature was taken with temporal scanner and also orally. I believe the oral thermometer showed a tempature of 99.7 F (not sure if this is the exact number, but it was roughly around this). Blood pressure was taken multiple times - I think the average was around 125 / 78. A doctor came to examine me and ask about my symptoms, previous allergic reactions, history of anaphylaxis. Overall, I was monitored for about 2 hours after the initial injection, and the dizziness had subsided by then. The nurse who administered my COVID vaccine strongly recommended that staff monitor me more closely for the second dose for any adverse side effects.
Information has been received from a healthcare worker referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored PROQUAD (lot # K011311, expiration date: 14-FEB-2016, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
R thigh swollen, red, non-tender, warm at site approximately 4 inches diameter vaccine given 8/22/02. Treated with Tylenol.
Rash, swelling, pain, pt was given Triamcinolone crm, Hydroxyzine and SEPTRA DS.
Left arm swelling, warm and tender, 12cm x 20cm raised with salmon color to it. No dyspnea or other rash on body.
This spontaneous case reported by a consumer, describes the occurrence of sinusitis (sinus infection), secretion/discharge (yellow mucus) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included sinus infection. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced sinusitis (sinus infection), secretion/discharge (yellow mucus) and headache. At the time of the report, sinusitis (sinus infection), secretion/discharge (yellow mucus) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Pfizer-BioNTech Covid-19 vaccine EUA. 3 x 3 inch red welt, hot to touch at injection site. Fever of 101.5 beginning 19 hours after injection. Fever ongoing 48 hours after injection (has not ceased as of yet).  Body aches, especially lower back, swollen lymph nodes throughout entire body, chills, lethargy, lack of appetite, dizziness, mild headache. There is a large swollen lump under collarbone about 4 inches and is raised from skin. Also pain under left armpit.  Since this occurred over the weekend, I plan to follow up with primary care doctor Monday.
About a week later I broke out in hives starting on my elbows. By that evening I was covered in welts and hives from head to toe. I went to the emergency room twice to get a prednisone shot and medication. I went to my family Dr and a Dermatologist. Since I have not changed any of my medication or household items it is believed to be from the Moderna vaccine.  I am still experiencing hives to this day. I am taking antihistamines for releif.
Information has been received from a lawyer concerning a male who was vaccinated with a dose of Pneumovax (manufacturer unknown) that had expired prior to administration. Subsequently, prior to 1999, the patient developed a pneumococcal infection. The patient sought unspecified medical attention. The outcome of the patient's pneumococcal infection was unknown. No further information is available.
Pain in left shoulder and arm terrebile pain went to clinic next day.Am on steroids but still can't raise left arm completly
On day 11 after 1st dose, woke up with a severe all over the body rash.. Red patches and very itchy and was spreading quickly.  Was put on steroid prednisone, Pepcid and Benadryl and was sent home. Rash went away for a couple hours and the next morning I woke up, the rash was all over my body worse than the previous morning. Itching non stop. Uncomfortable and wide spread. Went to the ER again and received more IVs and an epipen injection. Currently home from the hospital and my skin feels like it has a horrible sunburn and get intense itching attacks and painful pricks randomly throughout my skin.
Breakthrough case admission after 2 vaccines Moderna 3/31/21 Lot# 025B21A;  Moderna 4/30/21 lot# 048B21A