chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second shot (March 12),no adverse affects until one week later- March 19.  Abut 6 pm, severe chills, then fever of about 101 taken with forehead thermometer along with bad headache, nausea, and heartburn.  Took tylenol and Tums.  Fever lasted about 2 hours.  Headache, nausea and heartburn remained for next 6 day, until Friday morning, March 26.  But I woke up on Wednesday March 24 with an extremely sore Left top of scalp.  Called my Dr. for an appt- for Monday March 29.  Decided to go to Immediate care to tell them of my symptoms- of which headache, nausea and heartburn had gone away but now had pain on scalp.  They advised me to get a CT scan in the ER, but since I was feeling better and had a Dr. appt. didn't go.  That same evening I experienced tingling sensations on the L side of my torso, so wend to PIC and asked about Shingles.  Prescribed Valacyclir for 7 days.  Went to my Dr. on March 29 and she said to keep on taking Valacyclir- I have had no more pain on head or torso and no rash.  For the 6 days between March  19 and March 26, I could not work or do any other activities because of the extreme headache, nausea and heartburn.  When I picked up the Valacyclir, pharmacist said to report my symptoms to CDC.
Red welt and sensitivity at injection site, fatigue, overheating, insomnia, headaches, insatiable thirst, muscular pain and soreness all over body but mostly in low back, mid back, shoulders, and neck    All ongoing
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients was vaccinated with improperly stored dose of GARDASIL 9 lot number: M034780 and expiry date: 14-APR-2019) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for GARDASIL 9: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008387: US-009507513-1705USA012564: US-009507513-1705USA012562.
Gave IPV#4 that isn't due til age 4 years of age didn't give MMR or Varivax, Hep B and were out of Hep A.
Directly after this vaccine the child lost all speech, was ahead of her peers verbally and her speech regression was severe and significant. We also noticed no eye contact, loss of fine motor skills/playing, hand flapping, toe walking spinning. stimming, trouble sleeping. She now gets Speech therapy, occupational therapy, and ABA therapies to help with these symptoms and developmental regressions/delays. Her first assessment after the vaccine showed she was on about a 10 month old developmental level which prior to vaccine she had no developmental issues and had hit all milestones on time or ahead of the normal.
pt recv vax; Guillain Bare Synd; was on respirator; tingling in toes; hosp for 2 wk; currently in therapy;
Information has been received from a physician concerning a 20 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, the patient became light headed.  It was reported that they thought the patient may faint or pass out so they laid her down.  The patient was "ok" and left the office by herself.  At the time of the report, the patient had recovered.  Additional information has been requested.
1/6/2022- Presents to ED, via ambulance family unable to care for patient, deconditioned  and has fatigue, cough and SOB. Patient had IP stay 12/27-1/5/2022 for acute resp failure s/t CHF exacerbation and CAP, was on 2L NC, IV ceftriaxone and doxy.  Admit Covid + test. Given IV remdesivir, decadron, baricitinib, and doxy. 02 as needed,on 1-2L sat above 98%. Afebrile. 1/9/2022- Rectal bleeding, H&H stable. Sigmoidoscopy performed rectal mass suspicious for malignancy. VSS. Currently on 2L NC 98% sat. 1/10/2022- weaned from 02 use.  1/11/2022-Rectal mass path: adenocarcinoma. D/C decadron change to prednisone. IV doxy to PO doxy. VSS 1/12/2022- Covid hypoxia improving.  1/12/2022- Will f/u with colorectal  specialist post admission for surgical risk d/t antiplatelets and stenting. 1/15/2022- started on Rocephin, d/t possible UTI. 1/16/2022-BP's soft throughout day, 500cc bolus given , VSS. Rectal cancer stage IV.  1/17/2022-Had CT CAP showed liver mets. Will f/u with onc. for chemo after admission. VSS. H&H stable.  1/20/2022- H&H dropped to 7.3 1 unit given.  1/21/2022- Covid antigen negative.  1/23/2022- Hgb 9.5 improved and stable. Continues to maintain Spo2 level on 1-2L nc.  2/1/2022-Palliative Radiation tx, tolerated well. TX mon- friday.  2/6/2022-Hgb 6.8 transfused 1 unit. Pt diaphoretic, dyspenic and substernal pain. Trop indeterminate 0.027. EKG- aberrant conduction along with nonspecific T wave changes. D-Dimer 2,118.  CXR- small pleural effusion noted. 60 mg Lasix given. Steroids and Bipap. Moved to CCU. BP found to be in the &0's Levophed started. Pt is extremely drowsy.  2/7/2022- Levophed now off. On 3L NC now.  2/8/2022-Chest pain resolved. Trop peaked overnight 0.136. TTE ordered. Continue DAPT. Chest CT- no definite pe, large b/l pleural effusions. Bilateral upper lobe dependent atelectasis.  2/9/2022- Stable on 3L NC. Contne intermittent albumin doses with Lasix to mobilize fluid, refused thoracentesis.  2/10/2022- Downgraded to NT3. Stable on 2L NC.  2/17/2022- VSS and Hgb stable, tolerating 2-3 L NC.  2/18/2022- D/C to SNF for deconditioning, Will follow up with oncology and GI. Surgery not an option.
One day after: vomited several times, lethargic, loss of appetite. Two days after: hyporesponsiveness, hypotonia, pale skin, no eating , not smiling or reacting to us. Three day after: same.
Stomach pain, headache, nose bleed, hair loss, nail picking, anxiety, Raynards phenomenon, painful periods, body pain, left eye droop, lack of energy
after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.; affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve; affected person experienced ongoing headache at the time and later resolved.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.), MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.), MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.). At the time of the report, COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.) outcome was unknown and MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.         No concomitant medication information provided. No treatment medication information provided.  The reporter reported that starting day 3 symptoms started to improve.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
arm turned red like a rash; sore arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.  On an unknown date, the patient experienced ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching). At the time of the report, ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
I have had expected side effects such as soreness at injection site and achy joints/muscles, but I have also had diarrhea every day since receiving the vaccine. The Pfizer vaccine instruction sheet says symptoms (if any) may last 2-3 days, but this is day 5 with diarrhea each day, so I wanted to report it just so the data is captured.  The other symptoms resolved by day 3. Thank you.
arm became red, hot & swollen 4-6inches in diameter;itchy & very painful;instructed to use ice, DPH & Motrin;
Approximately one hour after vaccine - tingling to upper lip. Feeling flushed, some tightness to chest. Sl headache. Returned to health center. Temp 97.2 BP 122/80 P. 64 R. 16. Apulse 72. LS clear all fields, peak flow 95% at 375 L/min. Oxygen Sat. 99%. Within 10-15 min. SOB, tightness in chest worse, swelling to lips. 911 called. Taken to ER. Stayed overnight. Returned to hosp. ER hosp. another night.
Information has been received from an 82 year old female patient with no known drug reactions-allergies and medical history, who on 16-DEC-2008 were vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL tablets and SYNTHROID. On 28-DEC-2008 the patient started feeling back pain. Later her right side (arm, hip and stomach) started hurting and a couple of days ago she started experiencing the rash on her right side that looked like measles. Her physician determined it was shingles. There were not laboratory studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Follow-up information has been received from a physician who reported that the patient was vaccinated into the right arm with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #663196/1417X). Two weeks post vaccination on 30-DEC-2008 the patient developed right abdominal/flank shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. Additional information has been requested.
p/ pt recv vax approx 1yr later pt devel atypical breakthrough rash,  in addition unspecified bacterial cultures were positive
Chills, extreme fatigue, sore muscles & joints. Started a few hours after shot and still going next day
Patient came in to pharmacy MC stating that she feels she had a reaction to COVID vaccine that she received on 11/21/21. She began to experience "hot flashes" and nausea. She stated she had "chills" but is afebrile and not experiencing diaphoresis at this moment. She stated that symptoms began on 11/22/21. She was not ill at the time nor taking any medications as per patient.  Today she is not experiencing any distress, fever,  nor SOB.  Currently, experiencing seasonal allergy symptoms.
Pt was given Tdap on 5-14-13 as ordered by nurse practitioner. Pt returned to clinic on 5-17-13 and asked us to look at her arm. Pt stated arm was red, warm and had large knot where injection given. I looked at injection site and the injection was not given in correct location. It was given in deltoid muscle - was given too low and therefore SQ. It had quarter sized knot but redness had subsided. Told pt to monitor area but the knot would be present for several weeks. Also had NP look at her arm with same instructions. Nurse that administered injections was counseled and re-taught correct IM placement for injection.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sore throat since day after vaccination Have used Chloraseptic which temporarily helps Still experiencing it, for the third day now
Patient reports two days after vaccination noticed persistent left arm/shoulder pain. Patient denies reporting shoulder pain to employee health or provider. Patient reports discomfort did not go away and approximately in January had decreased range of motion to the left arm from the shoulder area with numbness/tingling in fingers. Patient denies seeking medical attention. Patient reports today March 20, 2019 decreased ROM to left arm/shoulder and at times numbness and tingling in the left hand fingers. March 20, 2019 when patient followed up with Employee Health regarding potential adverse reaction declined further follow up and care. PA for employee health notified.
severe diarrhea; cramps; vomiting; This is a spontaneous report from a contactable male consumer reported for himself. A 68-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via unspecified route, in left arm on 12Feb2021 13:00 (at 68-years age) 1st dose, single for covid-19 immunisation. The patient's medical history included heart disease. The had allergies to medications, food, or other products. Concomitant medications that patient received in 2 weeks of vaccination include clopidogrel (CLOPIDOGREL); losartan (LOSARTAN); rosuvastatin (ROSUVASTATIN); amlodipine (AMLODIPINE). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was Doctor's office or urgent care. On 13Feb2021 at 01:00 AM about 12 hours after the shot the patient had experienced severe diarrhea, cramps and vomiting. The patient had not received any treatment. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Redness, swelling, and warmth to touch on area around injection site. (Right thigh). No treatment necessary as beginning to heal.
Resident received the COVID vaccine on 1/19/2021.  On Sunday, 1/24/2021, she started to have chills and fever.  She stated her fever was 100.  On Tuesday, 1/26/2021, she went to Urgent Care, a CXR was done and MD said it was pneumonia.   Resident was administered Ceftriaxone Sodium IM and has a prescription for Levofloxacin daily.
This spontaneous report was received from a doctor of pharmacy concerning a patient with unspecified gender, age, pertinent medical history or drug reactions / allergies. Pharmacist reported that two weeks ago on 24-AUG-2012, the patient was vaccinated with MMR II and VARIVAX (Merck) (dose, route were not reported). No concomitant medications were reported. On an unknown date, the patient recently tested positive for HIV from a rapid test. The patient sought unspecified medical attention. Treatment was not reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Arm pain - s/p injection on Wednesday. Has had pain, noticed redness & swelling. Meds: vancomycin, KEFLEX, WBC 23.7.
On 04/07/09 pt. presented to the office with a rash for 1 day.Exam reveiled approx. 100 vesicular lesions scattered about, primarily on the torso. Mild upper respiratory symptoms.Afebrile.Tx.Aveeno bathes. Benadryl.Tylenol.Isolation.No ASA.
15 Y/O PATIENT PASSED OUT AFTER RECEIVING TWO VACCINES ( FLUCEVAX AND COVID 19 BIVALENT PFIZER-BIONTECH). PHARMACIST ASK HER FATHER FOR HELP, SHE REGAINED CONSCIOSNESS AND APROXIMATLY 60 SECONDS SHE PASSES OUT AGAIN. PHARMACIST HAD A TECH TO CALL 911 AND ALSO A PHARMACY TECH THAT IS ALSO EMT. AFTER 911 LISTENED TO THE SITUATION AND ASSESSED THEY ELECT NOT TO COME. PATIENT  FATHER EXPLAINED THAT THIS IS SOMETHING THAT HAPPENED EVERYTIME THAT PATIENT IS ON PAIN SINCE SHE WAS 3 YERAS OLD. PATIENT REGAINED CONSCIOUSNESS AND ENDED UP LEAVING WITH THE FATER AFTER WAIT AROUND 20 MINUTES SIT DOWN IN THE WAITING AREA.
Dosage 1, (8/25/2021): shortness of breath, elevated heart rate, and cold sweats as well as nuchal pain and numbness and tingling in the L side of the face lasting 3 hours. Dosage 2, (9/15/21): L sided body numbness and tingling resolving after 4 hours; generalized malaise for 6 days post injection.
Heart arrhythmia; This is a spontaneous report from a contactable Other Health Professional. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231), intramuscularly in Right arm on 26Jan2021 01:00 at single dose for COVID-19 immunisation. Medical history included HTN (hypertension), BPH (benign prostatic hyperplasia). Concomitant medication in two weeks included lisinopril, tamsulosin hydrochloride (TAMULOSIN), ergocalciferol (VIT D).  Facility type vaccine: Public Health Clinic/Veterans Administration facility. If other vaccine in four weeks: No. The patient previously took naproxen and experienced allergies: Naproxen.  If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced heart arrhythmia (medically significant) on 29Jan2021 12:00 with outcome of not recovered. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Holter monitor.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the event heart arrhythmia is considered as unrelated to suspect vaccine BNT162B2. The patient is most likely due to underlying cardiovascular conditions. 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.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient claims immunizations were given too high in left arm and is experiencing tingling/nerve pain. Patient is employee at a different store than given at. Advised patient to work with PM/SM and HR for a doctor visit. Rph told patient shots given to high, was not verified where given.
Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first or second dose of GARDASIL. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Follow up information confirmed that no known patient was identified or involved with the event. Therefore, WAES # 0702USA03638 is being deleted from our files. The report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007
Brain bleeding; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 for covid-19 immunization (lot number: EN6198; location: Right arm) The patient experienced brain bleeding on 21Mar2021 19:30. The patient was hospitalized for brain bleeding for 11 days on an unspecified date. The event was also assessed as life-threatening by the reporter.  The patient underwent lab tests and procedures which included nasal swab: unknown on an unspecified date. Treatment for the event was reported as unknown. Outcome of the event was not recovered.
1. Persistent Tinnitus in right ear and sporadic  tinnitus in left ear. Ringing sound has increased over time.  Began in April 2022 and has persisted to date. ENT prescribed methylprednisone 4mg but has not helped.   2. Since April 2022, I experienced pressure in right ear which has since abated.   3. Sporadic tingling in toes and fingers. Fatigue, elevated blood pressure. Began March 2022.
shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA282000 and 2019SA282001 (same reporter).  This case involves a 87 years old male patient who received a dose vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on an unknown date (reported as yesterday) by mistake.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  Patient had no adverse reaction.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.