chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sibling in office getting MMR and Varicella Vaccines. These vaccines were inadvertently given to patient at 1 month of age.
Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere but worse in my legs. Constant nausea, could not taste or smell food, watery diarrhea, profound weakness, extreme fatigue, nightmares.
Information has been received from a post marketing surveillance study concerning a 2 month old female. On 04/21/00, the infant received Prevnar, Hib, DTaP, Hepatitis B vaccine, IPV. The same day, upon awakening from a nap, she appeared to be choking on saliva. The infant developed pallor for approximately 5 to 10 minutes. She was seen in the ER and was found to have developed a fever of 101.2 degrees. At this visit the infant was diagnosed with fever with possible seizure vs. possible aspiration vs. reflux episode. Parents refused admission preferring to return to the hospital if necessary. These events were considered to be medically important. Choking and fever are expected; pallor is unexpected. As of 04/06/01, both medical monitor and investigator's assessment of relatedness is unknown. Follow up info received on 11/12/2001 clarified the description of the reported events. On 04/21/2000, while sleeping, the child "turned blue quit breathing, and was shaking, and salivating at the mouth." The child was treated with Tylenol. No personal history of seizure activity was noted. The child has since recovered with no recurrence of similar events following subsequent vaccinations.
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 23-year-old female patient who received RABAVERT. The patient's past medical history included animal bite (she was bitten on her back by a bat). Concomitant products included RABAVERT and RABAVERT. On 20th November 2017, the patient received the 3rd dose of RABAVERT. In November 2017, less than a week after receiving RABAVERT, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to RABAVERT. Additional details were reported as follows: The reporter was the patient's mother. The patient's mother was an employee of the facility where the vaccine was given to her daughter and because the mother was questioning the process and how the vaccine was given. The reporter had been told by hospital administrator's she was causing trouble. The reporter noted the bat was not caught and was trying to just be an advocate for her daughter. She stated she was told by site manager of facility that the manufacturer had been contacted and everything was fine. This was 1 of 3 cases, reported by same reporter for same patient.
Temperature 102-103 started 05/01/04.  Also mild rash on 05/01/04 progressively rash got worse, all over when see in office o n05/04/04.
Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got up to leave and then felt palpitations; VS: BP 122/81, HR 74, O2 sat 97% on RA Pulse regular She sat down and symptoms resolved. Patient then left to go home, and was instructed to seek help if she felt worse.
been dizzy; Potassium down; This case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis.   In June 2019, the patient received Shingrix and PREVNAR 13. In June 2019, less than a day after receiving Shingrix, the patient experienced dizziness and potassium decreased. On an unknown date, the outcome of the dizziness was unknown and the outcome of the potassium decreased was not recovered/not resolved.   It was unknown if the reporter considered the dizziness and potassium decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix and Prevenar 13 last week at the same time at pharmacy. The patient did not know, if the administered vaccines bringing her potassium down. The patient ate banana and felt little better, but in the morning of reporting day, the patient woke up and felt dizzy again.
MOC reports fever of 104. Patient was taken to ER. Labs and X-rays were done. Results normal. Patient discharged and advised to follow-up the next day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High LDL" (unspecified if ongoing), notes: Other medical history: High LDL; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel. The patient's concomitant medications were not reported. Past drug history included: Tagamet, reaction(s): "known allergies: Tagamet", notes: known allergies: Tagamet.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Was Negative for Covid tests by 30Dec; (Jan2023) Negative, notes: Was negative again by the 10Jan; (Jan2023) Positive, notes: positive covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
3-4 days after 2nd dose, large areas of bruising on arms (bilat), torso (all areas) and one on left thigh. Increase of pedal edema from Trace/1+ to 2-3+. Unexplained breaking of all finger nails. No pain or itching (pruritus) associated with bruises. No new meds (Rx or OTC) started during the week prior to first injection to this day. No real symptoms to treat so nothing done. Areas of bruising hace increased but are now starting to fade. No specific treatments done as there was nothing to be done other than to consult my PCP.
Patient presented to the ED with acute onset right calf pain, in the absence of trauma or injury, 5 days after receiving the 2nd dose of the Pfizer Covid vaccine. He reported flulike symptoms and being fairly sedentary in that time. He was found to have a lesser saphenous vein embolism that did not require anticoagulation.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Date of administration of vaccine was 24-Oct-2021 to 27-Oct-2021.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L209) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, PANTOPRAZOLE, MELOXICAM and TAMSULOSIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of diarrhea, a causal relationship cannot be excluded.
Pt recvd Engerix-B & 24JAN92 neg titer;
Information has been received from a physician concerning a healthy 9 year old male with no prior history of clinical chicken pox and no allergies who on 10/14/96 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 617264/0565D). Concomitant medication included ibuprofen. It was noted that no rash occurred at the site of injection post vaccination. Subsequently, the patient developed herpes zoster (onset unspecified) which was reportedly described as a very painful zoster on his arm and shoulder. The pain was so severe that the patient's arm was in a sling. The patient was scheduled to be seen by his physician on 7/1/04. The physician noted that a lesion specimen would be submitted for polymerase chain reaction analysis. Additional information was received from a physician who indicated that the patient developed herpes zoster. It was described as a shingle-type rash with 50 to 100 lesions on the right arm, forearm, thumb, and second finger. A specimen from a vesicular lesion was obtained on 7/1/04 and was sent to a laboratory for varicella zoster virus identification on 7/7/04. It was noted that the patient had no recent exposure to chicken pox or shingles. Subsequently, the patient recovered and at the time of the report was doing well. Additional information was received which indicated that the specimen arrived at the laboratory on 7/8/04. The result from the varicella zoster viral identification polymerase chain reaction test indicated that it was an adequate specimen and was vaccine strain varicella zoster virus. B-globin DNA was not amplified. Upon internal review, herpes zoster was determined to be other important medical event (OMIC). Additional information has been requested.
Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid  based on the known safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Date of Admission: 11/29/2022   Date of Discharge: 12/5/2022   Hospital Principal Problem (Discharge Diagnoses): Acute on chronic diastolic CHF (congestive heart failure) (CMS/HCC)   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: Acute on chronic diastolic CHF (congestive heart failure) (CMS/HCC) o COVID o TIA (transient ischemic attack) o Facial droop o Acute on chronic CHF (NYHA class III, ACC/AHA stage C) (CMS/HCC) o New onset a-fib (CMS/HCC) o Elevated troponin o Late onset Alzheimer's disease without behavioral disturbance (CMS/HCC) o History of CVA (cerebrovascular accident) o Essential hypertension
Information has been received from a registered pharmacist (R.Ph.) concerning an 86 year old female patient. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency, and lot number were not reported). On an unknown date the patient was diagnosed with lymphoma. It was reported that the patient was not taking any immunosuppressive medication and there had been no hospitalization. At the time of the report, the patient's outcome unknown. It was unspecified if the patient sought medical attention. The relatedness for lymphoma was unknown for ZOSTAVAX. As per internal procedure, lymphoma has been considered to be an other important medical event. Additional information has been requested.
Arm soreness at injection site, fever, chills, fatigue on following Saturday and Sunday.  Severe insomnia on following Monday and Wednesday.
About 1 month after shot patient experienced tightness & cramping in left shoulder & neck. Was seen by a Dr. prescribed VICODIN and FLEXERIL. Seen by a chiropractor who said he could feel tight muscles. Pain is only relieved by VICODIN or laying down.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 27 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-JUL-2021, the patient experienced a low grade fever. On 07-JUL-2021, patient had loss of taste, smell and was coughing. On 10-JUL-2021, the patient underwent SARS COV-2 antigen test and results came as positive (suspected clinical vaccination failure, suspected covid-19 infection). It was reported that the patient's felt his symptoms would have probably worst without the vaccination. The patient had not seen his health case professional at the time of this report. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not void (meet PQC) based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000185601.; Sender's Comments: V0: 20210723839-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS: Suspected Vaccination failure.
Information has been received from a physician, which was reported to him by a colleague, who is an infectious disease specialist, who reported that a pt had similar experience to the pt referred in WAES0307USA02888 (pneumococcal sepsis, disseminated intravascular coagulation (DIC), stroke, and loss of fingers), following vaccination with pneumococcal vaccine 23 polyvalent. The physician mentioned specific details were not available. Pneumococcal sepsis, disseminated intravascular sepsis, stroke, and loss of fingers were considered other important medical events (OMIC). Additional info has been requested.
Initial report received on 07/Aug/2006 from a health care professional. A 37-year-old female patient with no illnesses and a history of hypertension had received a right deltoid dose of Decavac in 2006. The route of administration , lot number, and specific date of vaccination were not reported. Approximately 48 hours post-immunization, the patient developed swelling, tenderness, and extensive redness approximately three inches in diameter and itching. The Decavac may have been administered with a 5/8 or 1/2 inch needle. Treatment received was not reported. Reportedly, the patient recovered completely in approximately one week. The reporter for this case is the same as for case 2006-02087.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Oct2022 to 08Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19 Positive after first dose; Tested COVID-19 positive so did not receive the vaccine second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive after first dose) and INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (COVID-19 Positive after first dose) and INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose). On 24-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Tested COVID-19 positive so did not receive the vaccine second dose) had resolved. At the time of the report, COVID-19 (COVID-19 Positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: inconclusive (Positive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided. 21Apr2021 and had not received the vaccine.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Patient in observation. Patient complains of swelling  on left arm at vaccination site.  Patients vital signs taken BP: 180/91, HR: 86, O2%: 98%. Patient in passenger seat. Notified regional lead RN. Administered Benadryl  20ml oral. Patient monitored for 30 minutes. Patents arm assessed. Swelling appears to decrease. Patient verbally agreed the swelling went down. Patient educated about side effects and when to seek further medical  attention if needed. Patient verbalizes understanding.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted and fell down forward, scratched his face. He gained consciousness in few seconds. we lifted his feet, cooled him down and took his BP. PB was normal. Paramedics checked him out and he was released within few minutes. He didn't want to go to the hospital for more work-up.
51 y/o male sitting in car, observation area post vaccination. Witnessed syncopal by RN, lasted 1 minute, no complaints. Fully recovered upon EMS arrival. States has history of syncopal reactions to injections. Fully alert and oriented. Refused transport.
ringing in ears; anxiety; depression; been detrimental to her mental health; hasn't been able to do anything, very inactive, and his getting worse; hasn't been able to do anything, very inactive, and his getting worse; This is a spontaneous report from a Contactable consumer (Patients husband).   A 60-year-old female patient received first dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration around 06Mar2021 (reporter was unsure of the exact date patient received the first dose, but he says it was around 06Mar2021) at the age of 60-year-old, Time the Vaccination Was Given: in the early morning around 9AM, as dose 1, single for Covid-19 immunization. The patient did not have any medical history and concomitant medications. She had No other history with this product. It was stated that 2 days after first dose, the patient experienced ringing in her ears it was a reaction and it hasn't gone away. It has been detrimental to her mental health. She has had anxiety and depression, the ringing doesn't go away. She has been going to therapy but it doesn't go away. She has been taking medication to calm her down but it still doesn't. No further information provided. Reporter wanted to know if they know anything about it, if there is anyway to undo the vaccine or if Pfizer has found anything that is useful because at this point she is going through a lot and he is going to have to take her to the hospital. The patient didn't take the second dose because of the ringing in the ears. It was stated that she had not just ringing in her ears but anxiety and depression". She hasn't been able to do any-thing, very inactive, and getting worse. They have the potential of going to the hospital emergency. Reporter stated they "will continue to work with the physicians, trying to manage how we can handle this". Reporter also stated that the patient have talked with people (privacy) and they have experienced similar symptoms. The patient did not undergo any investigation assessment. There was not any additional Vaccines Administered on Same Date of the Pfizer Suspect: None, Prior Vaccinations (within four weeks prior to the first administration date of the suspect vaccine). The event did not lead to Emergency Room visit however lead to visit to a Physician Office. The outcome of the events was unknown.   Additional Information on lot/batch number has been requested.
Evening of shot ran a fever, cold chills, teeth chattering, fever broke by morning, that's the worst of it. But my arm has been so sore - even now I feel it. Had it Sep 16 now Nov 13 still sore.