chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Came down with a cold; FLU LIKE SYMPTOMS; This case was reported by a consumer via call center representative and described the occurrence of cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received Shingrix. On 26th August 2019, less than a day after receiving Shingrix, the patient experienced cold and influenza-like symptoms. On an unknown date, the outcome of the cold was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the cold and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient reported that he came down with a cold after receiving Shingrix. The patient also experienced flu like symptoms. The patient did not consent to follow-up. The caller refused to answer any questions.
Information has been received from a healthcare worker referring to two patients of unknown age and gender. On unknown dates the two patients were vaccinated with improperly stored ROTATEQ (oral, lot # K023535, expiration date: 22-MAY-2016, dose was not reported). No adverse effects reported. Additional information has been requested.
Information has been received from a Nurse Practitioner concerning a female consumer who approximately a year ago in approximately March 2007 was vaccinated SQ with 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, within the last month (approximately February 2008) the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There were no lab studies performed. There was no product quality complaint involved. Additional information has been requested.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) milliliter. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Concomitant medication was not reported. The Treatment medication was not reported. The patient received two dose of COVID -19 vaccine with one additional dose. Only removed a vial from the freezer and put in the refrigerator the day before administered. The vaccines were not in the fridge for more than a day unless patients did not appear for vaccination.
Fever 101-103 degrees for over 24 hours at time of filing form. An increase in asthma symptoms. sore throat. at time of filing symptoms are not resolved. Will be returning to physician in the morning, urgent care clinic visit due to it will be a saturday.
Patient developed cellulitis in the left arm where all three injections were given.  Patient went to emergency room and received antibiotics, which they are still currently taking and were advised to come back to the ER if things get worse.
Patient devleoped herpes zoster on the left side of the body, where vaccine was administered.
massive headaches beginning in Feb99 which resolved sometime in 1999. Nite sweats beginning in July99 and resolved in Aug99; breathing problems beginning in Aug 99. 12/12/99 admitted to hospital for cough, fever.1/26/2000 admitted to NH for cough dx with eosinophilic pnuemonia 9/17/07-records received for DOS 12/22-12/24/99-admitted with 2 week history of fever, cough most lately with some hemoptysis, 10 pound weight loss. Shortness of breath, lungs clear. Impression:bilateral apical infiltrates, rule out tuberculosis, rule out atypical viral disease
Received less than half the dose; Needle Leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked). On 30-Mar-2021, UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Shot- slight swelling golf ball size in muscle.  Felt sick to stomach, arm hurt.  Sent home by boss.
Day 1. Fatigue. Sleepiness. Loss of appetite  Day 2. Muscle aches. Headache. Chills. Loss of appetite.   Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting  Day 3. Fatigue. Headache. Chest pain.
Mother reported noticing redness-purplish color, edema and induration around injection site morning of 3/12/2014. No fever. Able to move arm without difficulty. Referred pt to pediatrician for recommendations. No d/c from site.
This spontaneous report as received from a healthcare worker refers to a 9 years old patient. The patient was vaccinated with a dose of 0.5ml PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
PATIENT WAS GIVEN EXPIRED VACCINE, PER MODERNA WEBSITE, BATCH #036A21A EXPIRED ON 26AUG2021 AND VACCINE WAS ADMINISTERED ON 30AUG2021.
Mass Vaccination came for second dose in series and was to be monitored by EMS personnel for 30 minutes. EMS noted that patient was not "looking well". Patient assessed by EMS: BP 168/100, HR 120, O2Sat 98%. Patient self-administered 50 mg Benadryl PO. EMS administered 125mg solumedrol. At 1407 another 25mg of Benadryl administered. At 1412, BP 146/92, HR 112, O2Sat 99%. Patient continued to be monitored until patient felt better and wished to leave. Patient refused transport to ER.  Patient advised to follow up with PCP as needed or report to ER for further need.
Evening of 4-21-21, I fell asleep in chair, phone in hand (has never happened before).  My husband put me to bed.  He left town early morning, 4-22-21.  He could not reach me later in morning, had neighbor check on me around 12:30 p.m.  I was unresponsive, paramedics were called.  I presented as a stroke.  I couldn't wake up, talk, move, with left side weekness.  I was taken to Hospital.  Cat scan and MRI were normal.  Hospital labeled it Toxic Encephalopathy.  Spent two nights at hoapital, released Saturday 4-24-21.
Patient developed a fever/chills, nausea, and vomiting within along with a significant local reaction ( 9 x 7 cm area of erythema/induration) at the injection site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 02-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel fever 2hr later 101.7 R;sz 815PM;seen @ hosp transferred to hosp for observation;t102.6R;temp 102 AM;sz, jerking, staring, v, pale,unresponsive, eyes dec;fatigue;diff walking;LDH 246, hemoglobin 10.9, glucose 155;
Low blood pressure; This case was reported by a consumer via call center representative and described the occurrence of low blood pressure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high (patient informed that he normally had high blood pressure).   On 5th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown.   It was unknown if the reporter considered the low blood pressure to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient informed that he got his first dose of Shingrix last friday.  The patient stated that he normally had high blood pressure, but the following day, his blood pressure was low.  The patient did not report any symptoms with the low blood pressure.  The patient had followed up with his health care professional. The patient continued to had lower than his normal blood pressure. The patient enquired if there were any reports of this associated with the Shingrix vaccine.  The reporter did not consent to follow-up.
I DEVELOPED SOME SORT OF RASH OR HIVES ON MY UPPER CHEST, BUT IT DOESN'T ITCH. THERE ARE 2 SPOTS NEXT TO EACH OTHER. ONE IS ABOUT 2x2 INCHES, AND THE OTHER IS ABOUT HALF ITS SIZE. I FIRST NOTICED IT 5 DAYS AFTER HAVING MY FIRST VACCINE DOSE.
Case previously recorded as MA2009-3259. Received the following information from a consumer on the 23 Oct 2009. This 49-year-old male patient, was vaccinated with 0.5 ml, intramuscular S-OIV FLUVIRIN (batch number unknown) on 21 Oct 2009. The patient experienced injection site reaction (blanching at injection site) FLUVIRIN administration. Concomitant medication was not reported.
I GOT A FEVER SUDDENLY ON 01/23 OF 102.1 WITH BODY ACHES. I HAD A FEVER 3 DAYS THAT WOULD DROP THEN SPIKE. 1 ST DAY 102.1  2ND DAY 100.3 3RD DAY 100.5 BY 4TH DAY I WAS BETTER. NO FEVER BUT HAD A LOSS OF SMELL AND TASTE FOR ABOUT A 1 WEEK.
I started to have tingling/numbness in my extremities (hand and feet) at night when I slept and than it turned into during the day. This came out of no where and have never experienced something like this to the point I cannot sleep without waking up after 45 minutes to shake out my hands and feet. Very scary and painful.
Patient described had a high fever for 4 days total. Treated at hospital on 6-4-10, noted administered TORADOL and Rx - Tx LEVAQUIN AB Tx 3 days.
hypoxia; Flushing; itching; rash; coughing; wheezing; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0169), via an unspecified route of administration, administered in left arm on 05Aug2021 09:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma and hypothyroid. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had known allergies: Penicillin, latex, nickel, avacados, bananas and erythromycin. Concomitant medication included cyproterone acetate, ethinylestradiol (XYLIA). The patient experienced flushing, itching, rash, coughing, wheezing and hypoxia on 05Aug2021 09:45. The events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the patient. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included albuterol inhaler, BENADRYL and TYLENOL. The outcome of the events was unknown.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event hypoxia cannot be excluded.
76 y/o female with history of nephrolithiasis, Follicular cell lymphoma currently on treatment, DM II who p/w AKI. The patient was sent over from by Dr due to abnormal labs with AKI. Patient has no history of CKD that is known. In the ER, patient had Cr 6.7 with BUN 44. CT scan shows an 8mm stone with moderate left hydronephrosis. The patient also had ground glass opacities in the lung c/w covid pna. The patient has had a cough for about a week and has been tired. Covid swab came back positive after I saw the patient. Her daughter is in the room with her and notes she has started to have a cough as well. The patient denies sob or fevers. She notes she has a history of nephrolithiasis with prior lithot lithotripsy also noting she has had stenting in the past but caused discomfort. Dr. in the ER has discussed the patient with Dr of nephrology and Dr of urology. Admission requested.     Histories  Past Medical History: -DM II non-insuln dependent -HTN -angiosarcoma of the breast -Follicular cell lymphoma currently under treatment, last chemotherapy was in Oct, was supposed to receive chemo again today but sent here due to abnl labs (missed Dec chemo for Christmas).  02/16/2022 - currently inpatient of COVID stepdown unit.
Information has been received from a physician and a medical student concerning an "about 60 year" old female patient with a history of splenectomy who on 10-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23. It was reported that on 30-SEP-2009 the patient was diagnosed with meningitis. The patient was hospitalized at an unspecified facility. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Information has been received from a physician concerning a 2-month-old female who was vaccinated PO with a first dose of Rotateq. Subsequently the patient experienced 6 weeks of diarrhea (6-10 watery stools per day). The physician also reported that the patient experienced "three 15 second episodes of limp and was put on a abda monitor". The second and third doses of Rotateq were discontinued. The outcome was recovered on 24-MAR-2007. No further information was provided. There was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Dizziness starting 30 minutes with flu vaccine until on 2 hours later. Patient returned to Clinic and rested under observation.
PATIENT EXPERIENCED MILD TO MODERATE PAIN WITHIN SEVERAL DAYS POST VACCINATION.  AFTER APPROXIMATELY A WEEK AFTER THE ADMINISTRATION OF THE VACCINE, PATIENT BEGAN TO NOTICE A LARGE BRUISE EXTENDING DOWN HIS ARM AND A HARDENED LUMP AT THE SITE OF VACCINATION, THIS CONTINUED TO WORESN INTO LATE DECEMBER (1 MONTH AFTER RECIEVING THE VACCINE).  PATIENT ALSO REPORTED WORSENING PAIN IN THIS TIME PERIOD ALONG WITH DECREASED RANGE OF MOTION.  THESE SYMPTOMS WERE LIMITED TO PATIENT'S ARM AND UPPER BODY AND DID NOT SPREAD "SYSTEMICALLY" ACCORDING TO PATIENT.
No adverse events noted, patient did not have any reaction after 15 minutes of observation. When immunization documented in the Immunization Program noted that this dose was the patient's fourth dose. Immediately called patient and informed of immunization being patient's fourth COVID-19 immunization with two other doses administered at another facility. Pt denied receiving immunization at the facility. Clinic called to confirm which they informed this RN that patient did receive both doses. Patient's ID verified with name, date of birth and address. Patient called to update and patient informed this RN that she did receive the immunizations there. Informed patient that this is her fourth dose and that a VAERS would be reported.
Some pain over my lateral left hip like a week later and then next day woke up with visceral lesions and had shingles, the doctor prescribed Valtrex and it went away in 3 days.
Second Shot not Received placing ouside the 36 day window; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window). On 05-Dec-2020, PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. No treatment information was provided.; Sender's Comments: This report refers to a case of Product Dose Omission Issue for mRNA-1273  with no associated AEs.
More prone to bruising, but instead of healing in 4-5days, healing now takes 2-3 days.  Cuts and abrasions also take half the time to heal than normal. Wondering if platelet clotting has been affected.
Sore Arm; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 19th April 2019, refer case US2019AMR158286).   On 3rd July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, fatigue and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient received Shingrix and had local sore arm for 2 days and fatigue, headache for 24 hours. The reporter consented to follow up.
16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause.  She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.
pt recvd vax & states that had a pos HTLV blood test which was done the same day flu shot given;
L thigh bright red huge welt, Hives all over, onset less than 10 minutes post vaccine.
Patient received flu shot in November and was allergic! She had to go to an urgent care for treatment.
pt complains of chest tightness dizziness was treated on scene for CP transported by EMS to local ED
Slight Soreness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jan2021 18:00 (Lot number: EN5318) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild Hypothyroidism", start date: 2019 (ongoing), notes: Take Synthroid (Levothyroxine); "Ulcerative colitis", start date: 2019 (ongoing), notes: Use Remicade & 10 wks infusion. immunosuppressed due to the use of the TNF blocker REMICADE for UC; "CA R+ Breast", start date: 2002, stop date: Jul2002, notes: Lumpectomy- no lymphs involvement- 4 chemo + radiation, No recurrence 19 years; "Pain" (ongoing); "Anti-inflammatory", start date: 2020 (ongoing); "immunosuppressed" (unspecified if ongoing), notes: immunosuppressed due to the use of the TNF blocker REMICADE for UC. Concomitant medication(s) included: CELECOXIB taken for antiinflammatory therapy, start date: 2020 (ongoing); ACETAMINOPHEN taken for pain; SYNTHROID taken for hypothyroidism (ongoing); REMICADE taken for colitis ulcerative, start date: 05Jul2021. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Slight Soreness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter considered the Pfizer product had a casual effect to the adverse event. Patient received dose 2 (Batch/Lot number: EL9269) on 19Feb2021 18:00 and dose 3 (Batch/Lot number: FF2588) on 07Sep2021 15:00. Use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine and biologic therapies like rituximab and etanercept) Infliximab (Remicade) TNF blocker. Vaccination Facility Type: Pharmacy or Drug Store. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was none. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was none. Reporter stated that she was reporting this because she was one of those auto-immune patients not studied or not studied well in Covid vaccine testing/trials. Reporter thought this might be useful to get a feel for how booster reacted after 8+ weeks post Remicade. Reporter also sated that the autoimmune patients are some of many health groups you did little to no studies on when testing this drug. It was strictly because of the immunosuppression from medication that she took the third vaccine. Patient had no response to the first one, except a sore arm and a mild fever for a few hours on the second. When she received the third shot she was 8 weeks from her Remicade infusion, an her reaction was much greater.   No follow-up attempts are possible. No further information is expected.
within 48hours of third dose of Pfizer covid vaccine developed Lipschutz ulcers on her vulva.  no fever
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 24-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 24-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.