chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tremors; Sharp shooting abdominal and intestinal pain; Sharp shooting abdominal and intestinal pain; Tingling; This is a spontaneous report from a non-contactable nurse, the patient. A 34-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced tremors, tingling sharp shooting abdominal and intestinal pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events tremors, tingling Sharp shooting abdominal and intestinal pain was recovering at this time of report.   No follow-up attempts are possible. No further information is expected
Fever 101 F, severe aches  in all muscles, foggy thinking, migraine, dizziness, weird brain zap, mild nausea, mild diarrhea , inability to sleep
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
p/vax pt exp varicella lesions on back w/some itching & was afeb;
A week after receiving the booster I went in for scheduled pre surgery testing. The testing showed irregular heart rate, irregular EKG, blood work was out of whack. My surgery was cancelled and I was scheduled to see a cardiologist. I wore a heart monitor for fourteen days, I went through a stress test and an echocardiogram. These test showed I have PVC's I fluid retention in my lower extremities. I am now on seven new medications.
Patient experienced 1 month of intermittent diarrhea and vomiting after 1st rotavirus on 31 Oct 06.  After 2nd rotavirus on 23 Jan 07- patient started with vomiting and diarrhea.
patient stated she is still experiencing pain around the injection site....she showed me the area and it is very red and spotchy with bruising in multiple spots around the injection sight.  She also stated the area is warm to the touch
Information has been received from a nurse practitioner concerning her daughter who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL, 0.5ml intramuscularly. The nurse practitioner stated her daughter was tested positive for HPV on a PAP smear after completing the GARDASIL vaccine series, on an unspecified date. The patient was seen at the office. Additional information has been requested.
Information has been received from a certified medical assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a "high-grade" positive HPV on a PAP smear. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
A report has been received from pharmacist concerning a patient of unknown gender. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Pharmacist inadvertently administered 2 doses (0.2mL) of a FLUMIST (intranasal) into one nostril of an adult patient on 10-Nov-2015 in the evening. FLUMIST was administered in a pharmacy setting. Pharmacist who administered FLUMIST told that they had problems with the divider of the device and thus full syringe was inadvertently administered in one nostril. Patient did not experience any adverse effects following the administration. Reporter was not the same pharmacist who administered the FLUMIST. It was reported that there was no product complaint in place, the pharmacist who administered the dose was new to that product and was unsure of its administration process. The product itself was fine, no defect, no PQC. Pharmacist was not aware. The outcome of the event of single nostril administration was unknown. The reporter assessed the event of single nostril administration to be non serious.
Loss of balance, recurring migraine. These symptoms began with my first dose of vaccine on 02/11/2021 and worsened greatly with the booster on 11/30/21.
behavioral change; very moody; irritable; tired; angry; throwing hour long fits, then goes back to being ok and happy
received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient who received an expired dose of (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 21-Oct-2022, the patient received expired 0.5 ml, third dose of suspect HIB (PRP/T) VACCINE  with unknown formulation (lot UJ583AB, expiry date:15-Oct-2022) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a physician concerning a 13 year old female who was vaccinated with a second dose of Gardasil in her left arm.  Subsequently, the patient felt dizzy as she started to walk to the bathroom.  She became even more dizzy she decided to sit down on the floor and she fainted.  The patient was not injured she didn't hit her head.  The patient was placed in a supine position where cold rags were applied.  It was reported that the patient rested for a while.  The patient recovered from that event. This is in follow-up to report(s) previously submitted on 9/12/2007.  Information has been received from a physician concerning a 13 year old female who was vaccinated with a second dose of GARDASIL in her left arm.  Subsequently the patient felt dizzy as she started to walk to the bathroom.  She became even more dizzy she decided to sit down on the floor and then fell over.  The patient was not injured she didn't hit her head or loose conciousness.  The patient was placed in a supine position for the 25 minutes during Pulse and BP were normal.  Cold rags were applied.  It was reported that the patient rested for a while and left with her father.  The patient admitted to being fasting since 26-Aug-2007, 7:00PM.  The patient recovered from that event.  No product quality complaint was involved.
BAD SHORTNESS OF BREATH; COUGH / DRY COUGH; TIGHTNESS ON CHEST (TIGHTNESS LASTS 30 MIN); FEELS WEAK; DIARRHEA; THROWING UP; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight, rheumatoid arthritis, high blood pressure, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced diarrhea. On MAR-2021, the patient experienced throwing up. On MAY-2021, the patient experienced bad shortness of breath. On MAY-2021, the patient experienced cough / dry cough. On MAY-2021, the patient experienced tightness on chest (tightness lasts 30 min). On MAY-2021, the patient experienced feels weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and throwing up, had not recovered from bad shortness of breath, cough / dry cough, and tightness on chest (tightness lasts 30 min), and the outcome of feels weak was not reported. This report was non-serious.
10/5/12 headache, heaviness in chest, sore throat myalgia, swelling, flushed, both eyes swollen. 10/6/12 headache, joints ached.
I received the Shingrix vaccine in my upper left arm around 11.30am on Tuesday July 9, 2019. Around 5:30 that evening I became very lethargic and began experiencing pain in my joints. I had pain in both ankles (like they were sprained) and in my knees. I also experienced pain in my left wrist. I slept until about 2am when I woke up shivering and bathed in sweat. I had a severe migraine and was congested. I also urinated about 10 times that evening.
Renal left eye coagulation and couldn't see from left eye; Couldn't see from left eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included no adverse drug reaction (No Medical history reported.). Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN E NOS and CENTRUM VITAMINTS.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) (seriousness criterion medically significant) and VISION BLURRED (Couldn't see from left eye). At the time of the report, RETINAL ARTERY OCCLUSION (Renal left eye coagulation and couldn't see from left eye) and VISION BLURRED (Couldn't see from left eye) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.   This case was linked; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. Crossed linked
Moderna Dose 1 3/16/21 (013A21A) Moderna Dose 2 4/29/21 (025B21A) COVID Positive 1/2/22  1/2/22: 69-year-old female with past medical history of rheumatoid arthritis, diabetes mellitus, hyperlipidemia, obesity, pacemaker placement, previously treated pulmonary embolism presents with worsening shortness of breath.  As per patient she has been sick with pneumonia for the last 5-6 weeks.  She has been trialed on multiple antibiotics however has had persistent symptoms.  She presented to the ED in mid December and was discharged for treatment of pneumonia.  Over the last couple of days the patient has developed a nonproductive cough and worsening shortness of breath.  Patient has been tested multiple times for COVID and has been negative.  In the ED the patient want to be hypoxic with pulse ox at 86%; the patient is persistent requiring 4 L nasal cannula.  Chest x-ray is showing bilateral pneumonia.  1/15/22: At 10:37 on 1/15/22, ACLS protocol initiated d/t PEA. Pt received 4 rounds of epinephrine, 3 rounds of bicarb and 1 round of calcium. Pt's son and POA was contacted and agree that continuation of ACLS would be futile and decided to stop resuscitation. Pt expired at 10:54.
Swelling, redness, high fever 102.1, Pain gave Benadryl and ER visit.
Patient has a history of anaphylaxis to augmentin. She was waiting her 30 minutes post vaccine. Immediately she tasted metal and her chest felt tight. Patient was nervous prior to shot. I had her sit down, checked her blood pressure (it was normal). Patient then complained of itching all over. Patient was given 50mg of Benadryl. After about 40 minutes, patient said her throat was itchy and was recommended to follow up at the ER since she did not want us to call emergency services. The patient never had any issues of throat tightness or trouble breathing.
scattered, diffuse erythema papules on front chest and upper back area, some of them with white head.  no tenderness/itching.
No other information was available at the time of this call; VAQTA on 6/7/2021, and another VAQT A on 7/7/2021; Patient received one dose of TWINRIX and two doses of VAQTA; Patient received one dose of TWINRIX and two doses of VAQTA; Medical assistant calls and reports a patient inadvertently received a third dose of; This spontaneous report as received from a Medical assistant concerning a 23-year-old patient, gender unspecifed. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 21-FEB-2020, the patient was vaccinated with a dose of hepatitis a vaccine inact, hepatitis b vaccine rhbsag (yeast)(TWINRIX) (dose, dose number, route, Lot #, anatomical location and expiration date were not reported).   On 07-JUN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (dose, dose number, route, Lot #, anatomical location and expiration date were not reported). The Medical assistant mentioned that the patient received a "third dose " (conflicting information was the secon dose of hepatitis a  vaccine, inactivated(VAQTA) reported ) of hepatitis a  vaccine, inactivated(VAQTA) lot # T040581, expiration date: 28-MAR-2022, reported as recently, on 07-JUL-2021 (dose, route, and  anatomical location were not reported).  No other information was available at the time of this call. No PQC reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T040581; expirationdate: 28-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Dizziness after sleeping; Soreness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 16Feb2021 13:30 (Lot Number: Ez9266) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included ibuprofen (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks prior to the vaccination. The patient was not tested for COVID post vaccination. On 17Feb2021 at 02:30, the patient experienced dizziness after sleeping, soreness, nausea and diarrhea. The patient did not receive treatment for the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Patient was vaccinated with the MMR (left thigh) and the Varivax vaccination (right thigh) at about 1:45 PM. Within about 5 minutes after given vaccination, the patient began having redness to area surrounding vaccination injection site extending about 1-2 inches from injection site, spreading to her buttocks. Patient progressed to having complaint of itching at site (not verbally but patient seen scratching at buttocks and legs). No sign or symptom of respiratory problems or complications. Provider notified and assessed patient. Provider ordered diphenhydramine HCL 12.5mg/5ml Liquid, t 1 tsp PO q 6-8hrs prn FCG or Rash. Patient given dose of Benadryl before leaving the clinic. Team Lead Registered Nurse also notified of patient conditon and was the one to give the patient the Benadryl and released patient 30 minutes after incident occurred and Benadryl given. Patient parent called within 2 hours after discharge from the clinic and stated patient doing much better, was playing and that the redness to her legs and buttocks was almost completely resolved. Patient's parent was given instructions on when they should bring patient back in to the clinic or to seek emergency medical attention. Understanding and compliance verbalized.
Numbness on left side of face; Degenerative arthritis in joints; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: RP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and basal skin cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cefixime (BIOXIN) and levofloxacin (LEVAQUIN) and experienced drug allergy. On 10Apr2021, the patient experienced numbness on left side of face and degenerative arthritis in joints. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Apr2021, the patient underwent antibody test (blood test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event experienced numbness on left side of face and degenerative arthritis in joints was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure; 10 weeks after second dose developed a mild case of shingles; received the first dose on 11/8/2019 second dose on 5/27/2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2020, the patient received the 2nd dose of Shingrix. On 8th November 2019, the patient received the 1st dose of Shingrix. On 27th May 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In August 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix vaccine on 8th November 2019 (for tolerance of 1st dose, refer case US2020254965) and 2nd dose on 27th May 2020, which led to lengthening of vaccination schedule. The patient experienced a mild case of shingles. This case was considered as suspected vaccination failure as details of laboratory confirmation test was unknown at the time of reporting. The reporter did not have lot number or expiration date information to provide.  The reporter consented to follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254965:same reporter, 1st dose
dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days; dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) and PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) and PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in refrigerator on 25-Apr-2022. The vial did not undergo any temperature excursion. It was reported patients were administered from 2 separate vials of same lot number. Dose administered on 27MAY2022 with beyond use date being on 25MAY2022 as per HCP from 2 separate vials from the same lot number.   Treatment was reported as unknown.    This case was linked to MOD-2022-583974 (Patient Link).