chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist (R. Ph) refers to a 52 years old female patients who on 25-JUL-2012 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (lot # unspecified). On 27-JUL-2012, the patient developed bumps and a rash all over their body after receiving zoster vaccine live. The patient contacted the pharmacist and received the treatment medications of ZYRTEC, but no lab diagnostics were performed. At the time of report, the patient had not recovered. Additional information has been requested.
pt described doing fine during initial observation period. She went grocery shopping and within about 3 hours of receiving the vaccine, her eyes swelled "like bugged out" and she had her blood pressure taken at home with a systolic measurement of 214. Someone else in her home checked the functioning of the B/P cuff and theirs measured normally. The patient rechecked hers at that point and it was 200+.  She does not had a history of hypertension and has never been on anti-hypertensives.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 25-NOV-2015 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
12/26/22 presents to ED for "breathing problem". PMHx of "afib, DM, HLD"
Had redness, soreness and itchiness for few days after initial shot.Went away in a few days with no problem.Nine days later same symptoms reappeared. Looked side effects on internet and article stated it was COVID arm and should go away in a few days.However article advised to report this to to site.
ERYTHEMA, PRURITIS RIGHT ARM SITE OF INJECTION, FEVER, COUGH. gIVEN 10 DAY COURSE AUGMENTIN.
Patient documented as receiving Moderna vaccination series 3/4/2021 and 4/4/2021.  Patient then received Pfizer on 8/12/2021- lot # FC3180 and dose 2 of Pfizer as documented on this report.  Patient has been flagged.
BRIEF OVERVIEW: Admission Date: 8/24/2023 Discharge Date: Aug 30, 2023 Discharge Disposition:  home or self care   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Neutropenic fever [D70.9, R50.81] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE:   86-year-old male with medical history of AFib, neutropenia, past alcohol abuse sober for 10 years, hyponatremia presented to the hospital for chest discomfort and confusion.  Patient was accompanied by his wife who helped provide the majority of the history.  Two days prior to hospitalization patient was experiencing a cough which is progressively gotten worse.  Nonproductive and not associated with any degree of dyspnea.  Has also been feeling generalized weakness and fatigue.  Was brought into the hospital for worsening confusion ultimately.  Has had 2 TIAs in the past.  On arrival to the hospital was febrile.  COVID-19 testing was positive.  No respiratory symptoms however.  Was also found to be hyponatremic at 126..  Chest x-ray was negative for acute infiltrate and patient was breathing comfortably on room air.  Patient was preemptively placed on cefepime for neutropenic fevers.  Patient was having fluctuating fevers throughout hospitalization.  Patient mentation also waxed and waned.  Did require hypertonic saline drip with quick resolution of hyponatremia and mentation changes.  Was found to be euvolemic and was put on a fluid restriction and sodium chloride tablets with continued improvement.  Fevers began to wane and patient remained afebrile for greater than 48 hours.  Blood cultures remain negative.  Pancytopenia workup was started however ultimately no specific cause was identified.  Has had follow-up with Hematology and Oncology as an outpatient who wanted to perform bone marrow biopsy several years ago however was declined by patient.  Did reach out to Hematology and Oncology who did not suggest any further inpatient workup and recommended referral for outpatient workup.  Patient is stable today and is requesting discharge home.  Will be discharged home with supportive cough medicine, referral to Hematology and Oncology.  Strict follow-up with PCP recommended within 5 days.
Chills started 7 hours after the vaccine. Chills, shivers & shakes went on for almost 8 hours that evening. I Could not eat dinner.  I was weak and didn't feel good the next couple of days.  Saturday 4/1012021 my left knee started hurting & still is bothering me.
Patient is fully vaccinated . Patient presented with Laryngitis and congestion. Patient ended up being COVID-19 positive.
Arm soreness, welts under Bilateral breast, Buttocks, severe headache x4 days,
try to call patient but line is busy. patient is 76 years and adacel is for patient up to 64 years old.
Information was received from a pharmacist concerning a 22 year old female who in "1992 when she was 5 years old", was vaccinated with a dose of RECOMBIVAX HB, manufacturer unknown. Subsequently, she developed hives. It was reported that the patient recovered. No quality complaint was involved. Additional information has been requested.
Seem to have larengitis as of mid day yesterday. Have completely lost my voice. Not sure if it?s an after effect of the vaccines (also had a flu shot) or if just caught something. Also have a light runny nose. No fever.
Pfizer vaccine for his first dose and the second dose was Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer vaccine for his first dose and the second dose was Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Burning chest pain in center of chest x 4 days.  chest pain came on within 24 hours of pfizer booster vaccine given 10/15/2021, and has continued.   Abnormal EKG, sent to ER.  o/w Healthy female.
Information has been received from an other health care professional (administrator) referring to multiple unspecified patients of unknown age and gender. Concomitant medication included sterile diluent. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. On multiple unspecified dates, the patients were administered improperly stored doses of M-M-R II (rHA) (lot #: R000551, expiration date: 08-JAN-2020; dose, strength, route, and frequency were not reported) or VARIVAX (lot #: R017641, expiration date: 20-JUN-2020; dose, strength, route, and frequency were not reported) for prophylaxis. The M-M-R II and VARIVAX both reconstituted with properly stored Merck sterile diluent. No adverse effects reported. The vaccines were expose to the temperature of 64 F for 9 hours 30 minutes. There was previous temperature excursion with unspecified temperature for an unspecified amount of time. The data logger was included. This is a non-valid report with no patient identifiers; Sender's Comments: US-009507513-1902USA005226.
rash/rash on the head; continues with itching/torso with itchiness; inflammation in the mouth; inflammation in the eyelids; body ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER2613 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 (Age at vaccination was 74 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 2 diabetes, hypertension from an unknown date and unknown if ongoing. The patient did not covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included losartan, bezafibrate, atorvastatin, fish oil taken for an unspecified indication, start and stop date were not reported. The patient did not take other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6198 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 09:45 hours (Age at vaccination was 74 years) as dose 1, single for COVID-19 immunization and experienced severe inflammation in the mouth, eyelids, rash on the head, torso with itchiness and body ache. The patient followed the recommended protocol by the responsible staff of vaccinations, applied first dose he waited 15 minutes, no secondary effects were manifested or allergic reactions. After 8 days, he noticed severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache, she didn't consider a reaction to the vaccine, but an allergy for having eaten almonds although there was no background (it was a mistake having considered it an allergy), she told a known doctor about the problem, who prescribed Loratadine and diet without fats, strawberries, eggs, dairy and chocolates, there was improvement and symptoms disappeared, she gave for a fact that everything was normal. On 28Mar2021 at 14:00 after the second dose, 7 or 8 days the same symptoms appeared again, not severe as with the first dose, few days the reactions disappeared, but the severe rash continues with itching, considered serious symptom related after receive Pfizer BioNTech vaccine, without completing the reaction time of minutes to 1 hour, but after. The patient underwent lab tests and procedures which included Antigen Covid-19 with nasal swab with result negative on 29Mar2021. The therapeutic measures were taken. The outcome of events Rash and Itching was not recovered and patient was recovered from rest of all events on unspecified date in 2021.  No follow up attempts are possible. No further information expected
She came back to clinic with red patches on her face and arms and complained of these are all itching.
Information has been received from a nurse practitioner concerning a female who on 10-SEP-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). On 02-OCT-2007 the patient experienced "dry zoster-like rash" on the buttocks, legs and scapula. There was itching associated with the rash but no "oozing." The patient sought unspecified medical attention. No labs or diagnostic studies were performed. As of 07-NOV-2007 the rash was cleared up however; the patient still experienced slight itching on her left interior thigh and scapula and was noted to be recovering. There was no product quality complaint. Additional information has been requested.
Red rash all over back, upper left arm and across stomach area. Gets more red with application of rash cream.
cough, fatigue, headache, sore throat admitted to hospital on 1/20 and discharged on 1/22
This patient was seen on 05/04/2001 for a well physical exam. The patient was given Hep B vaccine # 1 on 05/04/01. The Health Bureau was notified on 05/07/01 at 8 AM that the involved child had expired over the weekend. Autopsy states cause of death as sudden death in infancy. Autopsy also showed E. Coli septicemia.
Information has been received from a nurse practitioner concerning a female who "2-3 years ago' in approximately 2007 was vaccinated with the first dose of GARDASIL. Subsequently the patient had HPV that required several colposcopies. The nurse practitioner was not sure if the patient had HPV previous to vaccination. The nurse practitioner believed the patient might have gotten HPV from being sexually active. At the time of report, the patient's outcome was unknown. Additional information has been requested.
After the second dose and now again after the booster shot my tongue swelled on the left side. My taste has been affected and my tongue hurts. After the second dose this persisted for 3 months.
Dose 1, Fever 102.5, chill, sick and couldn't do anything next day 101 and felt bad for 3 days. Red and puffy till my elbow for 4-5 days. Dose 2, Fever, low grade fever 100.5 and until the next day. Middle of Aug2021. I went to doctor as I was feeling feel. I felt trouble peeing. Urgent care and it was UTI. I got 5-day antibiotics supply and a shot. I was fatigued. This month it happened again and this time there was blood in my urine. Fatigue. Went to the same urgent care. Gave me a shot and 10 days' supply of meds. Doctor changed the meds because of the culture. It was resistant to the medication.
PATIENT HAD NO MORE INDIGESTION AFTER TAKING VACCINE (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included indigestion. The patient was previously treated with famotidine for indigestion.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced subject had no more indigestion after taking vaccine (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had no more indigestion after taking vaccine (unexpected therapeutic effect) was not reported. This report was non-serious.
Client presented to vaccination site on 3/3/22. The client reported that she received a 1st dose of Janssen COVID vaccine on 06/18/21. Client reported having fainted one time in the morning the 2nd day after receiving her first dose of Janssen COVID vaccine. Client reported not eating something before she fainted because it occurred right after waking up. Client stated she did eat something on 3/3/22 before vaccination.  RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with the Moderna COVID vaccine. Per Dr. approval to proceed with Moderna COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Moderna COVID vaccine, LOT#:0425L21A on 3/3/22 . The client did not report any symptoms during the 30 minute observation period.  RN educated client on possible adverse reactions and when to seek EMS.
Baby given VYANESE doses after vaccines.  A couple of hours later hyperactive behavior had escalated more than normal.  Called pediatrician but did not make recommendations.  Doctor visit on 6/4/09 began treatment to detox body from vaccines.  Currently, hyperactivity on & off; can't focus.
PATIENT INITIALLY COMPLAINED OF LIGHT HEADEDNESS THAT PROGRESSED TO SWEATING AND SHAKING. LAYED PATIENT DOWN ON FLOOR AND MONITORED PULSE AND CALLED 911. HAD EPINEPHRINE HANDY. PATIENT THEN COMPLAINED OF TIGHT CHEST AND UPON DEEP BREATHS PROGRESSED TO WHEEZING. PATIENT STATED SHE WAS ALLERGIC TO EPINEPHRINE, BUT UPON FURTHER QUESTIONING SHE JUST HAD A RASH FROM IT BEFORE, SHE AGREED TO LET US ADMINISTER THE EPINEPHRINE;  RIGHT AFTER, AMBULANCE AND EMT STAFF TOOK PATIENT TO HOSPITAL.
Quarter sized blotchy red, raised area adjacent to imm. site (R) thigh afebrile.
Body Aches; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) and VACCINATION SITE PAIN (Soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (Body Aches) and VACCINATION SITE PAIN (Soreness). At the time of the report, MYALGIA (Body Aches) and VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella-zoster virus vaccine live instead of varicella virus vaccine live. The patient was supposed to be vaccinated with varicella virus vaccine live to prevent chickenpox. The physician reported that there was no product confusion. There was no product quality complaint involved. Additional information from the physician indicated that the problem with the product confusion was that both of the vaccines have varicella vaccine in one form or another on the product and that caused product confusion for the medica assistant. Additional information has been requested.
covid vaccine breakthrough   dose 1  3/3/21  011A21A dose 2 3/31/21  010M20A
NARRATIVE: COVID infection following COVID vaccine 06/04 Covid vaccine dose #1 (of1) tested for COVID during pre-procedure screening, but also reports cough, headache, myalgia, sore throat; COVID positive 12/09 pt. reports chills resolved, moderated cough, fever resolved, headache, loss of taste or smell with decreased appetite, myalgia the same and worsening SOB since COVID, Audible expiratory wheeze; prescribed albuterol for nebulizer and sent nebulizer machine 12/13 pt. reports improvement in symptoms, clinically resolved.
On Day 8, first appearance of a red patch 2' x 3' at injection site. Warm to the touch. Itchy. Still present on Day 9. NO BIG DEAL FOR ME, but thought it interesting for tracking purposes.
About 7-8 hours after HPV #1 on 8/18/08, the patient noted lightheadedness, slumped to floor and fell asleep. Patient awoke 2-3 hours later alert and oriented. No seizure activity or residual limb weakness, or aphasia.
received PROQUAD and MMR II at the same time on 7/30/2021 and developed red puffy eyes on 8/3/2021; received PROQUAD and MMR II at the same time on 7/30/2021 and developed red puffy eyes on 8/3/2021; received PROQUAD and MMR II at the same time on 7/30/2021; This spontaneous report has been received from a researcher referring to her friend's son, a 1-year-old male patient.  The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On 30-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis (doses, routes of administration, vaccination scheme frequencies, anatomical locations, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration).  On 03-AUG-2021, the patient developed red puffy eyes (periorbital swelling and ocular hyperaemia) that recovered on the same day. It was unknown if the patient sought medical attention, received treatment, or if any lab diagnostics or studies were performed.  The causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and the mentioned events was not reported.
Chills, Fever, Muscles and joint pain, Severe headache and numbness in my legs (MS possible triggered from Vaccine) Nausea
This spontaneous report was received from a Medical Assistant refers to an adult patient of unknown age and gender who on 01-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (exp date and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product narrative were updated.