chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized erythema and swelling at vaccination site on the left arm.  Normal motor function and no sensory deficit. Lymph glands not enlarged.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient received a dose of Shingles vaccine for free from county health department and experienced a mild case of shingle. The reporter stated that he/she would not receive the second dose. Additional Supportive Information: Follow up was not possible as no contact details were available.
Parotitis - Information has been received from a physician concerning a 30 year old male physician who was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient developed parotitiis.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient developed onset of right eye vision loss on 5/20/22 following date of booster shot 5/17/22. She additionally developed right sided headache and jaw claudication. Carotid duplex obtained which revealed acute thrombosis of her right internal carotid artery and large thrombus within the common cartoid artery. CTA obtained to confirm these. Findings. She has no prior history of carotid artery disease or strokes. She is additionally without significant history of underlying peripheral or coronary atherosclerotic disease. She is a nonsmoker.
I have an ostomy and had to be hospitalized from constipation. While in the hospital I had many tests ran to find out why I was constipated and to find out if I had a bowel obstruction. They did CBC comprehensive that came back negative; CAT scan of my abdomen that showed I did not have a bowel obstruction, X-ray of abdomen that showed I did not have a bowel obstruction, ferritin level blood work, positive for anemia, magnesium level blood work came back good, GFR estimated came back good; 12 lead EKG came back that everything is working properly; COVID-19 test came back negative; urinalysis came back negative; blood lipase came back negative. I am feeling much better, the doctors and I are working on a plan to help get my anemia back on track. This past week my blood pressure has been normal, and I wasn't even taking my taking my blood pressure medication.
On monday evening she started feeling bad. she had a sore throat and a dry cough and body aches. the next morning she had a sore arm, fever(100.7), chills, shooting pain in her hands and hips, and shortness of breath. By thursday 4/8 she developed a migraine that has continued along with all of these side effects. She took Tylenol to help with fever and pain.
Chronic diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Chronic diarrhea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Chronic diarrhea). At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            Concomitant medications includes were blood pressure medication. Treatment medications included were steroids medication. but when they stopped the steroids, the diarrhea started to come back again. Patient had received the 2nd dose in Jul-2021. Patient reported chronic diarrhea, and said had gotten all sorts of tests and everything came out negative. They even had a colonoscopy done.
One week after vaccination the vaccination site became itchy and I developed a rash with raised red bumps.  This lasted about  12-15 hours and then disappeared. Itchiness was intermittent, minor, and I did not take any medication for it.
Had 30-45 minutes of shortness of breath; Fever; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had 30-45 minutes of shortness of breath), PYREXIA (Fever) and MYALGIA (Muscle aches ) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shortness of breath (pre-existing medical condition that also causes similar shortness of breath).   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Had 30-45 minutes of shortness of breath), PYREXIA (Fever) and MYALGIA (Muscle aches ). On 12-Apr-2021, DYSPNOEA (Had 30-45 minutes of shortness of breath) had resolved. At the time of the report, PYREXIA (Fever) and MYALGIA (Muscle aches ) outcome was unknown.            Concomitant product use was not reported.  Treatment information included acetaminophen to help with the fever and muscle aches.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.
severe headache; unexceptional eye contact to light; high blood pressure; upset stomach; First dose on 25Apr2021, second dose on 10May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10May2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 25Apr2021, for COVID-19 Immunization, reaction(s): "Extremely fatigued", "Headache". The following information was reported: HEADACHE (hospitalization) with onset 10May2021, outcome "unknown", described as "severe headache"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "unexceptional eye contact to light"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10May2021, outcome "unknown", described as "First dose on 25Apr2021, second dose on 10May2021". In the evening of 10May2021, patient began to suffer a severe headache and he ended up at withheld. They kept overnight and kept a close eye on me, patient was a heart patient. The patient was hospitalized for headache (start date: 10May2021, discharge date: 11May2021, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of headache. Patient did not receive anything for pain until 2 a.m. of 10May2021. Patient was given Naproxin and was sent home with a prescription for the same. Patient continued to remain at home on 12May2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness and swelling at the site of injection 8 days after receipt of the Moderna Covid vaccine.  Size was 2-3 inches in diameter and warm to touch with mild discomfort.
Fever 103F, Shaking Chills Responded to Tylenol.  Afebrile 12 hours later
pt recv vax & had a violent reaction of n/v,d, etc that lasted approx 1 wk;
Woke up with top lip swollen, tiny blisters the entire circumference of lips, for 3 days total. Blisters would subside in afternoon and return in morning. After 3rd day, lips were peeling.
Tiredness; Headache; Typical arm swelling; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 17th of the seventeen reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got the vaccine shot in the village along with friends and all had the typical arm swelling, headache and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Patient started experiencing chest tightness about 10 minutes after receiving her 1st Moderna shot
Headache, numbness, tingling to skin, nausea and vomiting x1.
Pfizer covid vaccine is administered using the 1mL vanish point syringe provided by manufacturer.  The needle has a self-retracting feature for safety.  During administration, the self-retracting feature was initiated and the patient did not receive the full dose of covid vaccine. the nurse witnessed splashing of medication outside of the patient's arm.  the patient did have a break in skin from the needle, but uncertain if full dose administered.  Supervisor, notified pharmacy and dr.  dr came to bedside, spoke with patient and consulted with dr. and dr.  in Pfizer vaccine vial, overfill dose of 0.2mL was ordered and administered. patient agreed. 0.2 mL supplemental dose was given as ordered.  pt given v-safe instructions and monitored for 15 minutes after last administration.
Flu like symptoms. Muscle and joint aches, fatigue. Bad the next morning then quickly disappeared about noon.  No issues since.
Fever, rash at injection site, red area at site, swelling, stiffness in body, not wanting to walk, discomfort, irritability. Not sleeping several weeks. No diagnosis.
Mild hives/itchiness on torso/ arms at 30-45 min post injection  Severe hives/itchiness on torso, arms and legs at 9 hours post injection  Respiration ok, unaffected; face/head unaffected as of 10 hrs post vax
Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (formulation: Solution for injection), via an unspecified route of administration in the Left arm on 01Feb2021 16:00 at single dose for covid-19 immunization. Medical history included asthma and Allergy to penicillin. Concomitant medication included drospirenone (SLYND), fish oil, vitamin D and berberine. On 01Feb2021, the patient experienced head ache, fever, chills, muscle soreness and soreness at injection site. On 01Feb2021, the patient underwent lab tests and procedures which included body temperature: fever. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Patient did not report any adverse reaction.  Pfizer vaccination series was given again at the recommendation of his oncologist.  Pt had a stem cell transplant 60 + days prior to getting this series of vaccine.   He had previously received his first 2 doses prior to the stem cell transplant..  Pt had antibody levels drawn post transplant and was found that all of his antibodies had been wiped out.  We vaccinated outside of the EUA
Initial unsolicited pregnancy report received from a nurse on 06-Feb-2018. This case involves a 17-year-old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (frequency: once, batch number, expiration date, dose in series and site of administration were not reported) via intramuscular route instead of ADACEL (batch number, expiration date was not reported) on 31-Jan-2018. She was 33.5 weeks pregnant at the time and the error was discovered today. Pregnancy information (LMP, estimated delivery date were not reported. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to wrong vaccine administered. No adverse event reported at this time. Patient's pregnancy outcome was not reported. 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 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. Follow-up information was received from a nurse on 18-May-2018. As per follow up information received on 18-May-2018, it was confirmed by the reporter that the correct vaccine ADACEL (correct vaccine) has been administered and hence DAPTACEL (wrong suspect vaccine, reported in the initial version) has been deleted. Patient had a medical history of epilepsy on an unknown date. Patient's last menstrual period date was 08-Jun-2017, estimated delivery date was 18-Mar-2018 and patient was in her 40 weeks of gestation. It was reported that patient's Apgar score was 6 and 8. Pregnancy information including patient's birth type was reported as live birth not otherwise specified and born by cesarean type. Lab data included patient was performed HIV test, hepatitis, immune to rubella antibody and Hepatitis B non-reactive (result: negative) on an unknown date. Patient was received MECLOZINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE (PNV) for pregnancy, and IRON for anemia, ZANTAC for heartburn and ZOLOFT for depression daily via oral route on 22-Aug-2017. List of documents held by sender: none.
hospitalized 8/3-8/9 J&J on 3/10/21. Positive on 7/25
low grade fever (99.5 - 99.8), cough, and intermittent swelling under right jaw 10 days after vaccine
incorrect age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incorrect age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication has been reported.
Severe GI bleeding.  This required hospitalization from 04/03/2021 - 04/10/2021, with no know source found for GL bleed.  I was admitted to medical Center with a Hemoglobin of 6 and received a total of 4 blood transfusions.  My hemoglobin was 7.4 upon discharge.  On Friday, morning, Apr 16, 2021, I was taken to Medical Center, and found to have a Hemoglobin of 4.8 with severe GI bleeding.  I received 3 blood transfusion and they found an atrial bleed in my small intestines.  Surgery was completed on that day to stop the bleeding at  Medical Center.  I was discharged at 11:30,  today, Apr 18,2021.
This spontaneous report was received from a registered nurse referring to a unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical histories were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (routes, doses, frequency and anatomical place of vaccinations were not provided), lot # K016311, expiration date 26-MAY-2016. The doses of the vaccine were exposed to 47.6 degrees F for 85 minutes before been administered. Concomitant therapies were not provided. No adverse effects reported. There was not product quality complain involved. This is one of several reports from the same source. Additional information has been requested. -
This a spontaneous report from a Pfizer-sponsored program from a non-contactable male consumer reported for himself. A currently 80 years old male patient of an unspecified ethnicity received when 69 years old PREVNAR, via an unspecified route of administration on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced stomach issues, muscle cramps, coughing up phlegm and night sweats on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
raised red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (raised red rash) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (raised red rash). At the time of the report, RASH ERYTHEMATOUS (raised red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
pt/ c/o dizziness, alert and verbally responsive , 0change LOC v/s 97%RA 81bpm, 19cpm, BP 140/90  Patient stable , symptoms improved. Patient sent home at 12:40pm
pt became very pale & was crying; mom picked pt up & pt went limp episode lasted 5-10mins; episode occurred @ home;
severe local reaction left upper arm.  Symptoms began evening of 11/4/08.  Warm to touch-reddness-swelling of arm above elbow.  Patient referred to urgent care for medical intervention 11/25/08 call to patient.  She recovered from event.
The patient received her Moderna booster dose (LOT#: 025L21B) on 02/13/22 at 1640. The pharmacist (RPh) alerted the RN that patient name was on Moderna booster participation form from Vial 2. The RPh stated she never pulled a full dose from Vial 2 and only boosters were pulled from Vial 2. The RN called the licensed vocational nurse (LVN) and she stated that she did remember having a patient who she thought received a full dose of Moderna but quickly realized she had given a Moderna booster. The RN called patient two times and left a voicemail to call back. Patient did not answer and has not called the RN back. The RN called the patient again the next morning and left a voicemail. Patient's son in law called back and gave the RN a new number to reach patient. The RN called new number and spoke to patient's daughter. The RN explained incident. Patient's daughter explained that they would be coming back to the vaccine site to receive Moderna dose (0.25 mL) in order to complete first dose of COVID-19 Moderna vaccine. Patient returned 2/14/22 at 1446 to receive Moderna (0.25 mL). A different RN assessed patient after completing 15 minute observation. Patient stated her head "felt big." Patient denied pressure, pain, and did not feel lightheaded. Patient left vaccine site unassisted and with a steady gait at 1503 with no adverse reactions.
First dose 26-May-2018 Second 09-Jul-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th May 2018).   On 9th July 2020, the patient received the 2nd dose of Shingrix. On 9th July 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist reported that a patient received 2nd dose late which led to lengthening of vaccination schedule. The reporter consented to follow up.
From telephone correspondence received at manufacturer on 12/11/02, it was reported that a 5 year old child received Tripedia (Lot # U0581AA) given in the left deltoid in August of 2002.  One to two days after vaccination, the pt developed swelling 3x size of arm. The area was red, warm and painful. It was diagnosed by the physician as Cellulitis.  No lab/diagnostic tests were needed, as it was very obvious.  The pt was not taking any other medication at time of vaccination, did not receive any other vaccinations within a 4 week time period, and did not have any illnesses or pre-existing diagnoses at time of vaccination.  The pt reportedly recovered from this event.  The case is closed.  See cases U2002-00494, U2002-01159, U2002-01160, U2002-001162 & U2002-01163 with same reporter.
Case number PHEH2014US009393 is an initial spontaneous report received from the physician assistant on 05 May 2014, with a follow up received from physician assistant on 06 Jun 2014. This report refers to a patient of unknown identifiers. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X13015, X13059) intramuscularly on 07 Apr 2014. It was reported that the patient received MenA lyophilized conjugate component reconstituted with a sterile diluent other than MenCYW-135 liquid conjugate. No adverse event was reported after the administration error. The physician assistant was unable to provide the patient identifiers. Follow up received from physician assistant on 06 Jun 2014: Updated physician assistant comment.
Ringing in ears started on Thurs around 11am (3/18) after Tuesday at 3:00pm injection (3/16). The ringing has been a high pitched frequency that has not changed in volume, tone and is constant. I went to audiologist and they detected notched hearing at 1500hz. I have not had any other symptoms and this has never happened before. The ringing has not stopped and it has been just over 3 weeks.
According to pt's note from the ED visit patient c/o redness, swelling and pain on the site of vaccine. Has had associated nausea and vomiting x1. Started antibiotics on 12/05 during visit at the ED with no improvement. Seen by PCP on 12/07 who started pt on BENADRYL and prednisone taper. Pt to be evaluated again on 12/09/15.
swelling of lt arm 3" diameter w/intense redness;hot arm to finger tips, hollowed by formation of firm mass 2" diameter @ center;sl dec use of arm;
Initial health care professional report received on 26 Apr 2010: This patient received inadvertently MENVEO (batch number unknown) only the MenCYW-135 liquid conjugate component of MENVEO intramuscularly whose batch was 090901 on 23 Apr 2010. It was reported that the nurse forgot to reconstitute the liquid component with the lyophilized component before vaccine administration. No adverse event had occurred.
patient developed swelling in the left arm,shoulder,left side of the neck within 24-48 hours of receiving the vaccination.Patient evaluated in the office;treated with a course of steroids with improvement/resolution of symptoms.