chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1620 C/O pressure in back of head which progressed to Dizziness and Weakness unable to stand no LOC, Oriented x4. VS BP 138/89,HR 82 reg, Resp 15,Sats 99%. Refused offer of rescue.1622 Placed on stretcher Ekg 12lead done. 1625 BP 121/76, HR 83,Resp 18. Expressed Dizziness improved. 1630off stretcher sitting on chair. Her husband is present. Monitored 15more mins. 1645 expressed Dizziness resolved. 1646Left for home ambulating with her husband. Educated on S/S to call 911
suspected vaccination failure; shingles / which presented as a quarter sized area of bumps/pain; pain on either my lower back or forehead; pain on either my lower back or forehead; Bumps; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mouth ulcer (suffered since childhood, and about 20 years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, low back pain, forehead headache and raised rash. On an unknown date, the outcome of the vaccination failure, shingles, low back pain, forehead headache and raised rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, low back pain, forehead headache and raised rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  A number of years ago from the reporting date, the patient was diagnosed with shingles which presented as a quarter sized area of bumps/pain on either of his/her lower back or forehead. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up was not required, as no contact details were available.
Out of it and not acting like herself; Dizzy; 2nd dose administered before 25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ABNORMAL BEHAVIOUR (Out of it and not acting like herself) and DIZZINESS (Dizzy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABNORMAL BEHAVIOUR (Out of it and not acting like herself) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and OFF LABEL USE (2nd dose administered before 25 days). At the time of the report, ABNORMAL BEHAVIOUR (Out of it and not acting like herself), DIZZINESS (Dizzy) and OFF LABEL USE (2nd dose administered before 25 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient that received the Moderna 2nd dose 28-MAY-2021 (Exp; 10-Apr-21)   22 days after the 1st dose. Patient's daughter reported that the patient was dizzy, out of it and not acting like her after the 2nd dose. The patient was admitted to the hospital.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.  No concomitant medicines were reported. No treatment information were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.
Inmate was a new intake into this facility. Inmate was offered the Janssen vaccine and he consented to receive. Inmate received the vaccine. Upon entering the information into the medical record, a documented history of Janssen vaccine was given on 4/27/21. Inmate did not require a second dose, but was not truthful on intake as to having previously received a vaccine. No adverse side effects reported as of the time of submitting this report.
First day - tired; 2nd day chills ,coughing , congestion ,and headache, super exhausted; little fever 99. Mucinex DM and Tylenol.  Tested positive for COVID on December 29th 2020 and quarantined. Symptoms lasted that whole week - 6-7 days.
Diffuse drug reaction rash on skin of arms, legs, palms, torso and scalp. Raised red rash with itching. Itching and rash noted on 20Dec in the evening and worsened to cover most of the body by 22Dec. Treatment as of now is oral prednisone, oral OTC antihistamines. Epsom salt soaks for relief.
BODY ACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, and the outcome of chills was not reported. This report was non-serious.
J&J given to 14 year old. Patient observed for 25 minutes. Department of Health contacted.
Pt describes a gradual onset of a pruitic rash starting on his neck, moving to his chest, abdomen, back , bilat arms and legs.
Patient had severe inflammation in the pectoralis muscle and redness and inflammation in the elbow/forearm area.
I experienced the swelling of the arm and pain the day after the shot for about 3 days, but I?m experiencing it again is that normal? Does the swelling happen twice? My whole arm itches, not severely but unusually itchy.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Body aches and chills, high fever, fatigue, congestion, headache began at 3:00am on 3/28/21 and lasted through 2:00pm on 3/29/21.  Treated with ibuprofen.
Very sore, hot, itchy injection site reaction. Developed fever first night that lasted for 4 days. Injection site still very sore, warm, and itchy.
After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient did not had any known allergies. Patient was treated with Paxlovid from 13Apr2022 to 18Apr2022.   No follow-up attempts are possible. No further information is expected.
Hoarseness at 7:00 followed by 101.6 degree fever at approximately 8:30 p.m  -- Fever of 102.3 reoccured on the morning and afternoon of 11/6/09.
Fever (oral 100.9), severe body aches, headache, ear ache, chills
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: Pharmacist reported that a patient received an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
This spontaneous report as received from a nurse refers to a 62 year old female patient. The patient's medical history was not reported. On 22-SEP-2014 (reported as yesterday) the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (Dose: 0.5 ml, Route: subcutaneous in the left arm) (lot # K002927 and expiry date: 16-FEB-2016) instead of ZOSTAVAX. Staff error only. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is lined to case # 1409USA012416 (same reporter link). Additional information is not expected as the reporter did not wish to contact.
Around 1:30 in the am, I woke up with terrible arm pain all the way down the arm, teeth chattering, major headache, and nausea.  My body ached all over. It began with arm pain, then, the chills and teeth chattering began.  An hour later I began to throw up. I threw up 4 times. Luckily I had some nausea pills (Promethazine 25mg) so I took that after the 4th time being nauseous. I should have went to the ER. The last part of the reaction was my body pain all over, especially my back.
p/vax pt exp pain @ inj site;exp muscle soreness in neck & back w/fatigue, rt arm weakness & noc sweats;pt also lost 24 pounds & felt very anxious & upset;sought unspecific med attention;
Patient woke up Saturday 8/14/2/20 with fatigue, body aches, sore throat, and headache. She had nausea with no vomiting. A fever of 99-100 degrees F was noted at home with chills. She presented today with the above complaints improving except for a worsening sore throat. On the physical exam today, she was afebrile. She had some pustular areas on her tonsils, and her strep test was negative. She also had some mild tonsillar nodes bilaterally. Her exam was otherwise unremarkable. She was told to take Ibuprofen/Tylenol for fever/aches/headache, gargle with warm salt water, and was given a prescription for an antibiotic to take in the event she had worsening symptoms.
Information has been received from a licensed practical nurse concerning a 70 year old male, with no illness at the time of vaccination, with no adverse events following prior vaccinations, whose reported weight was 197 pounds with hyperlipidaemia, hypertension, coronary artery disease, seasonal allergy, benign prostatic hypertrophy, glaucoma and myocardial infarction who on 27-SEP-2006 was vaccinated intramuscularly (IM) in the left deltoid with the second dose of Pneumovax 23 (Lot # 654981/0674F). On 27-SEP-2006 the patient developed cellulitis-like reaction at the injection site. The patient was seen in the Emergency Room (ER) and was released. At the time of the report it was unknown if the patient recovered. In follow-up it was reported that the patient's wife mentioned that her husband was in the ER for 6 hours. She would like a lot check performed immediately. She requested a response to her physician and herself as soon as possible. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. In follow-up it was reported by a license professional nurse that the patient developed cellulitis and lymphedema to the left upper extremity and severe pain after receiving Pneumovax in the left upper extremity about 11:00 or 11:15 a.m. on 27-SEP-2006. The patient was seen in the ER on 27-SEP-2006 at 8:00 p.m. and then at the clinic on 29-SEP-2006 and 02-OCT-2006. The patient was treated with ZYRTEC, ice and elevation and AUGMENTIN, 875 mg # 20. It was reported by the patient's wife on 24-OCT-2006, that the patient had started to recover, but his arm was still affected by the Pneumovax 23 and he still had pain in his arm. Additional information is not expected.
Patient was aware she might have a reaction to the covid vaccine as she reports a reaction to influenza and tetanus vaccines in the past. Patient received Janssen vaccine today. Patient brought along her own EpiPen and Benadryl as a precaution. Pharmacist advised patient to wait in the observation area for atleast 30 minutes to monitor for signs of an allergy. Patient's appointment was for 1355 and after vaccination around 1410 patient complained of a mild rash insides of both arms. Pharmacist advised her to take a Benadryl and continued to monitor for signs of anaphylaxis. After 20 minutes, patient left with no additional harm. Mild rash was still present but patient felt ok to leave home.
pt recv vax & exp an excessive sting while the vaccine was injected w/pain @ site;
Hospitalized 10/27/2021; COVID-19 positive 10/27/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: DO Admission Date: 10/27/2021 Discharge Date: 11/1/2021 HOSPITAL COURSE: Patient is a 32 yo male with history of Klippel-Trenaunay-Weber syndrome, stress induced CM, chronic lymphedema, and epilepsy. He was hospitalized on 10/27 concerning for sepsis and left lower extremity cellulitis as well as COVID19 pneumonia.  Patient was recently hospitalized from 9/23 thru 10/17 for sepsis shock/LLE cellulitis. Completed course of antibiotics two days prior to this admission. Noted to have had persistent erythema and above baseline swelling of left thigh and leg with associated warmth post DC. He was febrile prior to arrival and due to this and lethargy brought back to ED.  Workup on presentation showed a high CRP and D-Dimer as well as leukocytosis. COVID19 test also positive. CXR showed no acute process. Patient not hypoxic but with occasional recent cough. With regards to COVID19 he received monoclonal antibody. Started on Decadron 6 mg daily. Received Remdesivir. Lovenox SQ given at BID interval due to very high D Dimer.  In respect to his left leg a CT venogram study performed and showed findings consistent with extensive vascular malformation involving left lower extremity and superimposed infection was very difficult to exclude. ID followed and broad spectrum IV antibiotics narrowed to Rocephin. Plan for Amoxicillin 1 gram TID after DC to complete 14 days of treatment and then 1 gram BID for indefinitely suppression.   He had improvement in left lower extremity cellulitis symptoms. Discussed with hematology prior to DC given very high d dimer levels and DVT prophylaxis recs. They stated that given his high bleeding risk would recommend not pursuing anticoagulation after discharge and recommending progressive ambulation.  Discharge planning discussed with mother who was agreeable.
This spontaneous report as received from a Licensed Practical Nurse refers to a 5 months old patient. The patient was vaccinated intramuscularly with first dose of 0.5 ml pediatric VAQTA (lot number not reported) on 25-OCT-2012. No other co-suspects were reported. No concomitant medication were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient sought medical attention. Additional information has been requested.
Adacel was administered to a 12 month old patient with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient to whom diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] was administered 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 meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) and hpv vaccine vlp rl1 4v (yeast) (Gardasil) for immunisation.  On 28-Jun-2022, the patient received 1st dose of 0.5 ml, total, once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot U7117BA, expiry date: 15-Jul-2023, Strength: Standard, Suspension for injection, via intramuscular route in the thigh nos (did not know which thigh) for immunization.   On 28-Jun-2022 the patient developed a non-serious event as adacel was administered to a 12-month-old patient with no reported adverse event (product use issue) (Latency: same day). Caller was requesting information if the dose was valid and next step to taken.  Action taken was not applicable.  Outcome was Unknown.   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.; Sender's Comments:  01168833:
Fever of 101 for 12 hours dehydration, dry heaving, weakness, soreness.
pt presented 48hr p/vax w/acute urticarial reaction;wheals symmetrically distributed over arms & legs;no SOB;rx DPH & 1% HC topical;
Patient received his second dose of Moderna on 01/06/2022. It was 6 days early. Patient is being notified to come repeat the second dose since the one administered is invalid.  No signs or symptoms reported.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 01-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The both PROQUAD was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from  the same reporter.; Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003521: US-009507513-1801USA003520: US-009507513-1801USA003612 :
Pt was receving her 1st COVID-19 Pfizer booster vaccination. While nurse was administering the vaccine, the syringe hub separated from the syringe causing part of the vaccine to be administered while the rest spilt from the syringe.   Given the loss of vaccine, this administration was followed with a pediatric dose of pfizer after consent from the patient and her mother.
I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender's Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.  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 RAs, Ethics Committees, and Investigators, as appropriate.
This spontaneous rport as received from a physician who is also the patient's sister refers to a 26 year old female patient. In 2008 the patient was vaccinated wiht a first dose of GRADASIL (dose, lot # and expiration date were not reported). In 2008, after vaccination of GARDASIL, the patient experienced malkaise as she did not feel well and fatigue as she was very tired. The physician stated that "she is a difficult patient who did not want to pursue further doses". Therapy  with GARDASIL was discontinueed. At the time of the report the outcome of malaise and fatigue was unknown. Additional information has been requested.
Gradual onset body aches, fatigue w/fitful sleep that night, w/fever of 102F by patient report the next day, w/gradual, complete resolution of symptoms in 24 hours. No sequelae. Used OTC ibuprofen for symptom control.