chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up 3/27 left ear feels clogged hard to hear; Woke up 3/27 left ear feels clogged hard to hear; Woke up 3am heart racing; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: En6199) via unknown route of administration on 25Mar2021 01:15 PM (age at vaccination 52-year-old) as dose 2 single in left arm for COVID-19 immunization at Other. Medical history included migraine and COVID-19. Allergies to medications, food, or other products included Sulfa allergy. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included ascorbic acid (VIT C), ergocalciferol (VIT D) and montelukast sodium (SINGULAIR). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient woke up 3am heart racing on 27Mar2021 03:00 AM and Woke up 3/27 left ear feels clogged hard to hear on 27Mar2021 04:30. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient received treatment received for the adverse events. The outcome of event heart racing was recovered in 2021, while for others was unknown.  No follow-up attempts are needed. No further information is expected.
Redness, swelling and pain, right arm, Motrin PRN, Benadryl PRN
Approximate 4 3/4 cm circular area with some mild redness swelling, slightly warm to touch. No drainage present. Drew circle around swollen area. RN discussed with pt. to put cool compresses on area + administer BENADRYL. Also pt. advised to stop itching the are. To return if swelling worsens, have fever, or discharge.
After receiving the FluMist, my nose and sinuses began to burn. Over the next few days, I had periodic sinus pain. It was to the point that my eyes would water and I had to hold my nose to minimize the aching and burning. I felt unwell all over. It reminded me of the actual flu but less severe. Still, it was very uncomfortable, and I doubt I will get the FluMist again. Lasted about 5 days. (I received the H1N1 mist last year and didn't have any issues. Not sure why the mist this year bothered me.)
rt upper arm is very swollen 7 inches tenderness +induration, hard like rock w/yellowish central coloration;acute cellulitis rt upper arm;adm to hosp for observation;
Fever (101 plus), chills, body aches, severe diarrhea in a.m. morning after Flu shot, weakness, nausea with no vomiting x 2 days. Could not retain even H2O x 2 days.
received 1st dose of GARDASIL 9 about one year ago, received the second dose on 6/28/2021.; No PQC or additional AEs reported.; This spontaneous report was received from a pharmacist referring a 17 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported.  In approximately 2020 (reported as one year ago), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, batch/lot# and expiration date were not reported) for prophylaxis. On 28-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5ml, lot#: T028582, expiration date: 04-MAR-2023, strength was not reported) intramuscularly for prophylaxis. No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: T028582; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
01/26/2007 pt at after hours clinic with reddened left leg, hot to touch, hard, treatment Benadryl 1 T. 01/29/07 F/U phone call to mother redness, swelling mostly gone now. Afebrile.
20sept98 pt recv 1 dose of vax, 20sep98 pt devel fever 99.8, fever went to 103.8 where remained. pt had inflam of left ear, rhinitis & cough. m.d. had blood drawn, test norm values, pt not recv from fever/rhinitis/cough @ time of rpt
Anaphylaxis reaction; Angioedema; Shortness of breath; Wheezing; Fast heart rate; A spontaneous report was received from a physician concerning a 44-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylaxis reaction, angioedema, shortness of breath, wheezing, and increased heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 20 Jan 2021 at 18:00, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 20 Jan 2021, approximately 10 minutes after receiving her injection, the patient began to have tongue swelling. She was given diphenhydramine and epinephrine by epi pen. She went to the emergency room where she displayed symptoms including a fast heart rate, wheezing, and shortness of breath with an angioedema or anaphylaxis like appearance. She was given more epinephrine, famotidine, scheduled diphenhydramine at 50 QAs intravenously (IV), IV steroids, was intubated and placed on a ventilator. She was on the ventilator for approximately 18-20 hours following admission. She eventually responded to a high dose of dexamethasone. She was also given duonebs for her shortness of breath, regular sedation for the ventilator, and a dose of ketorolac. Consent was given for Safety to follow up.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown at the time of this report.; Reporter's Comments: This case concerns a 44 year old female patient who experienced a serious unexpected event of Anaphylactic reaction. The event occurred approximately 10 minutes after first dose of the study medication administration. She was treated with epinephrine, famotidine, diphenhydramine, IV steroids, intubated and placed on a ventilator.  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.
Patient woke from nap with unconsolable screaming and crying with knees rigid, choking on own saliva from being so upset. Remained like this the rest of the day and continued to be timid and not engaged like his normal self for three days.
Patient notified pharmacy that on 3-23-21 she woke with red spot at injection site.  Two days later it increased in size and became swollen and itchy.  Patient attempted cold compress which made it worse and Allegra.  Advised to try Benadryl and Cortisone cream and speak with physician if it continued to progress further.
I have been diagnosed with shingles--itchy, red bumps on the left side of my torso. I am currently treating them with Valtrex and a prescription ointment.  I am most disappointed not to be getting my second Covid vaccine due to this unfortunate side effect of my first Covid vaccine.
I've been on at the birth control pill for 23 years and had a  very light periods.  For the 1st time ever I had an extremely heavy period lasting 2 days longer having to use more pads daily and larger pads.  I also wake up now and have to change pads overnight and never had to do that.  I'm now on my 3rd period since the 1st vaccine shot and it continues to be extremely heavy with clots and cramping things. I have not experienced before since being on pill.
This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with PEDVAXHIB (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered to the patient on an unknown date was an improperly stored vaccine. But was unsure which ones, may have been MMR II, PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no product quality complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to: 1505USA014702 and 1505USA004646 (same patient link). Additional information has been requested.
seizure; apnea; high fever; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had high fever, seizure and apnea. The reporter requested that the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) be tested for contamination. The reporter was asking how the product should be stored. The outcome of high fever, seizure and apnea was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of seizure and apnea cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Weakness, fever, malaise, chills (1st week post vaccination). Still experiencing pain in legs, weakness in all limbs 3 weeks post-vaccination.
On 10/3/00, the pt experienced an injection site that was erythematous, hot to the touch, and very swollen, a very stiff neck. On 10/6/00, the pt notified employee health the the injection site was warm to the touch and that she had a 2" x 1" area of erythema and swelling. Neck was also mildly stiff.
I went to a regular wellness check up where we were going over blood work /thyroid function and vitamin levels. Everything came back that I was healthy. My blood pressure was good and I had no fever but I was in need of two vaccinations, which I got. The next Morning after my appointment I woke up with chills, body aches, couldn't move my arm, had a low grade fever and felt very tired. I did at home care of ibuprofen and lots of water. The next morning I could barley keep my eyes open, my whole body was in excruciating pain and I had a fever of 103. I was rushed to the ER. My blood pressure was low but my heart rate was high and the medication they gave me at the ER was not helping my blood pressure. I was admitted to the ICU in the hospital where I stayed under constant care for 4 days before being released. They did many test that all came back negative and my final diagnosis/ reason I was in the hospital is on record as septic shock (from a muscle infection in her arm or some other virus). I almost died and no one has a answer as to what caused it. I had a clean bill of health on Monday 2 days before being admitted to the ICU.
18NOV91 mom states pt broke out w/itching rash 17NOV91 also c/o difficulty breathing; 18NOV91 referred via phone to MD; 25NOV91 MD felt rash probable MMR reaction - difficulty breathing secondary to muscle spasm;
Patient came in on Friday 16 Jan 2009 complaining of excessive swelling at site of injection, redness, hardness, and hot to the touch.
This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown demographics. The GARDASIL (lot#, expiration date and route not reported) that underwent an unsupported temperature excursion "may have been administered" to these patients. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Patient presented to pharmacy 11/10/12 and got 1 injection of MENVEO vaccine. 11/11/12 pt found swelling, red, hard, hot at site of injection. 11/12/12 site was same if not slightly worse. Presented to another pharmacy location and was advised to call us and report reaction. Pt not alarmed and declined coming in to show.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number 661046/0381X) while she may have been pregnant. The last menstrual period reported as 06-JUL-2009. There were no adverse reactions reported. The patient saw a physician in the office. On 03-SEP-2009 a urine drug screen was performed and resulted for Cannabis. On 03-SEP-2009, the patient was given ZITHROMAX. At the time of the report, the outcome of the patient was not reported. Follow-up information has been received from the medical assistant concerning the 22 year old female with a history of one previous pregnancy and one full term delivery who on 28-JUL-2009, at 11:00 AM was vaccinated with the first dose of GARDASIL (lot number 661046/0381X) in the right arm. Prenatal vitamins were used daily since pregnancy. On 01-SEP-2009 an ultrasound was performed for the estimated date of conception. The result was normal intrauterine pregnancy. On 20-JAN-2010, the patient was vaccinated with a 0.5 ml dose of H1N1 (manufacturer unspecified). On an unspecified date, the patient developed yeast infection and was treated on 01-APR-2010 with TERAZOL 7 vaginal cream 0.4% for one time. On 08-APR-2010 the patient gave birth to a normal baby boy. The boy was 8 pounds and 8 ounces weight and 20.75 inches long. There was no complication during pregnancy and labor/delivery. There were no congenital anomalies or other complications with the infant. Additional information is not expected.
she had administered an expired dose of Daptacel to a patient, no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via unknown route in unknown administration site for Prophylactic vaccination [Expired product administered ]. The lot number and expiry date not reported.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Information has been received from a registered nurse concerning a female (age not reported) with no known medical history and/or drug reactions/allergies, who on 26-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil vaccine (lot # 657617/0384U). On 30-AUG-2007, the patient was vaccinated intramuscularly with the second 0.5 mL dose of Gardasil vaccine (lot # 657617/0384U). There was no concomitant medication. In July 2007, "1-2 weeks after receiving the first dose of Gardasil vaccine", the patient developed intermittent fevers to 103.9 Fahrenheit and a full body rash. The symptoms subsided and then reoccurred after the first dose and before the administration of the second dose of Gardasil vaccine. After receiving the second dose, the symptoms continued without change. The patient has seen her primary care physician many times for the symptoms but there is no cause found. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested. Follow up information obtained on 10-DEC-2007. The registered nurse reported that the white female patient (weighing 174 lbs) received both doses of GARDASIL in the left deltoid. On 16-OCT-2007 the patient called to report that itching, rash and fever occurred after receiving both doses of GARDASIL. The patient sought unspecified medical attention. The patient was treated with unspecified steroids dose pack. The patient recovered. There were no illnesses at time of vaccination or pre-existing allergies, birth defects, or medical conditions. Additional information has been requested.
4 1/2 hrs of high-pitched, uncontrollable crying; 1 cm mass on buttock;
Slight nausea set in around 9pm, along with headache. Headache and nausea intensified and remained through next day. Fever set in with chills, and maximum temperature recorded was 39.4C (digital non contact forehead measurements). Chrlls remained throughout through 4/14/20, ie 2 days. Extreme fatigue and "black-out-like sleep all of 4/13/21 (day after injection) through 4/14 am. . None of my prescriptions taken on 4/13/21 till about 8:30pm /4/13/21, when only the hydrocortisone full day dose was taken. Extreme thirst/oral dryness all of 4/13-14. Lost 5lbs between am 4/12/21 prior to inoculation and 2 days later (4/14/21 am). Fluids only refilled by Friday as per BDW. NO FOOD palatable or able to eat on 4/13/21 due to nausea, extreme fatigue,  except for 6oz milk to take with hydrocortisone ills. Alendronate missed on both 4/13/21 and 4/14/21.
Firmness, redness, warmth at injection site, area of erythema around injection site about 15 cm
erythematous, macular rash over extremities-especially upper legs; started 1 day p/vax; told to use DPH if it starts itching; some rash on trunk; afebrile;
Tiredness he had to go to bed; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness he had to go to bed) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (Tiredness he had to go to bed). On 08-Feb-2021, FATIGUE (Tiredness he had to go to bed) had resolved. Not applicable    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included Cholesterol medication and Blood pressure medication (Unspecified).  Treatment details was not provided.
PT was administered their 2nd dose of Pfizer, and started experiencing symptoms about 15 minutes later.  Stated that they have history of anxiety, and was having  a tightness in their throat.  Also was feeling a tingling and itching on their tongue.  PT was administered PO antihistamine 50mg.  PT cleared the site after waiting additional time under their own power.
Cellulitis 48 hrs after vaccine in left arm. Tx with Zithromax with good response.
Fever, chills, body aches, extreme fatigue, migraine, nausea, and inappetance. Lasted about 1 day, used Tylenol at home to keep fever down. By the next morning, only had slight fatigue and minor headache.
Persistent hives,  fever, croup cough, runny nose. Symptoms stared at  12 hours after getting the shot.
At site of administration, raised, red, painful. Seen at clinic 6/23, diagnosis is acute cellulitis. Treated with doxycycline 100mg BID x 10 days, BACTRIM 800/160mg BID x 10 days, hydroxyzine 10 mg 2 8H for itching.
I developed a very itchy red bumpy rash. Upper body front and back, hip area, both arms and neck front and back.
Covid vaccine #1 2/4/2021 Lot # 016M20A Moderna Patient was admitted to the hospital 10/8/2021 for acute respiratory failure and died 10/20/2021. This was not a Covid related death.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored oral, ROTATEQ, (dose, frequency and route were not reported). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pt completed 15 minute observation, returned to car, then started a reaction. Pt's husband requested assistance from police office in parking lot. Pt was found on passenger side of care, diaphoretic, reports buringing and pruritis of mouth and throat, and difficulty breathing. EMS called, epinephrine administered, and pt transported to hospital.
Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: In July, after receiving the vaccine the patient experienced injection site soreness in the upper right arm. The reporter did not consent to follow up.
Sun: got vaccine. Tue: 4 am started to have headache.  Wed: sore throat until Thu.  Thu: Went to work and started to cough, still coughing.  no fever.  today: cough, congestion, body pain but getting a little better.
no adverse effect; Improperly stored dose of PNEUMOVAX23 was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient'ss concurrent conditions, concomitant therapies, medical history, drug allergies or reactions were not reported.  On 07-JUL-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route of administration and anatomical location of vaccine were unknown) (lot # S029265 has been verified to be a valid lot number, expiration date was reported 31-MAR-2021), for prophylaxis.  The vaccine was exposed to a temperature between 12.1 °C for 2 hours and 20 minutes. No previous temperature excursion was reported. No adverse effects were reported. The report was received due to a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Chills first (whole body shivers), headahe,  30 minutes later, fever 30 minutes after headacher. Treated with 600mg ibuprofen.
Pt recv vax on 11/3/98; post vax pt exp irritability & vax site tenderness; tx=Tylenol
01/06/22 presents to ED for "fever". PMHx of "HTN, HLD, TBI, dementia, aortic aneurysm and epilepsy"