chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increased body odor/still start to smell bad a few hours after showering, even when not sweating; COVID test result: Positive (08Jan2021); COVID test result: Positive (08Jan2021); This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 13:15 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included ascorbic acid (VIT C), ascorbic acid, biotin, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, pantothenic acid, potassium iodide, pyridoxine hydrochloride, retinol, sodium selenate, zinc sulfate (CENTRUM MULTIGUMMIES MEN). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination; tested on 03Jan2021 with the results pending. On 08Jan2021, the patient has tested positive via nasal swab post vaccination. On 09Jan2021, the patient experienced increased body odor. The patient had resorted to showering twice a day, and still start to smell bad a few hours after showering, even when not sweating. No treatment was administered for the event "increased body odor/still start to smell bad a few hours after showering, even when not sweating". The event "increased body odor/still start to smell bad a few hours after showering, even when not sweating" had not resolved, while the outcome of the rest of the events was unknown.   Information about lot/batch number has been requested.
Severe headache that lasted 4 days. Could not lift or really use my left arm for almost a month without pain and weakness. Full body rash that lasted 2 months.
Red, warm Slight pain rash around injection site after second dose. No reaction noticed after first dose
Information has been received from a licensed practical nurse concerning a 12 month old female with no medical history or drug allergies who on 28-MAY-2009 was vaccinated with a half a dose of PNEUMOVAX 23, 0.25 ml. There was no concomitant medication. On 29-MAY-2009 the patient developed a fever as high as 103.7 degrees F. The patient sought medical attention by phone call. The nurse had spoken with the mother and the patient had recovered on 01-JUN-2009. Follow up information has been received from a licensed practical nurse concerning the patient with no illness at time of vaccination and no pre-existing allergies, birth defects, medical condition who on 28-MAY-2009 at 08:00AM was vaccinated with the first half dose of PNEUMOVAX 23 in the right upper thigh, 0.25 ml. On 29-MAY-2009 at 08:00AM the patient developed rash and a fever as high as 102 degrees F (previously reported as 103.7 degrees F). The patient had recovered on 02-JUN-2009 (previously reported as 01-JUN-2009). No further information is available.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA280692 same reporter for 10 years old. This case involves a 14 years old patient (gender unknown) (weight 63.5 kg) received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 23-Sep-1018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Intern gave a 14-year-old FLUBLOK QIV/no bad reactions reported. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
shingles/Supstected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 85-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, unknown after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine.     Additional Information: GSK Receipt Date: 22-JUL-2022. Reporter's Comments: The patient developed shingles after receipt of a shingles vaccine. The reporter was unsure which herpes zoster vaccine the patient received. The reporter had no further details at the time of reporting, regarding date of administration or lot/expiration date. The reporter attempted to ask for consent to contact but pharmacist was rushed off the phone. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Flu Vaccine was not administered correctly.  The dose was not injected into the muscle as recommended.
24 hours of fever of 101, body aches, weakness, chills, loss of appetite.  Soreness at injection site lasting three days.
This case was reported in a literature article and described the occurrence of swelling of tongue in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included hepatitis A vaccine inactivated  ;manufacturer unspecified given on an unspecified date; hepatitis B vaccine recombinant ;manufacturer unspecified;unknown given on an unspecified date; meningococcal acwy vaccine (non-gsk) ;Aventis Pasteur;unknown given on an unspecified date. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling of tongue and headache. The author considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unspecified. The author considered the events were considered to be potentially related to vaccination with BOOSTRIX.
May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (May have used an expired vial/Dose administered after 30-day Use By Date or after manufacturer date of expiry/full dose of expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Vial didn't undergo any temperature excursions. Pharmacist pulled the expired vial around 07:45 pm on April 5th and put in refrigerator. Refrigeration date of vial: 05-APR-2022 No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Reporter Mail added. Suspect information added. Narrative updated.
Extreme hyperactivity, unable to control himself or his behavior.  My son has been out of control since the vaccine.  He is unable to control his behavior, having trouble listening, following instructions. He has been compliant up until this vaccine.  This has been ongoing now for 3 days.
Mother reported increased swelling, redness, warmth day after vaccination. Patient scheduled for appointment 2/22/23 and noted to have swelling, warmth and blistering of injection site. Provider believed likely to be an exaggerated immunization reaction. However, given severity of reaction, treated empirically with Bactrim for possibility of cellulitis.
Information has been received from a nurse concerning a 12 month old female who in January or February 2007, was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccines included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of poliovirus vaccine inactivated (Vero). After receiving varicella virus vaccine live (Oka/Merck), the patient developed a varicella type rash with quite a few spots. No additional information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a physician stated that this Caucasian patient received a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 656281/1504F) on 27-MAR-2007 in the right arm. There was no illness at the time of vaccination and no allergies or medical history. There were no adverse events following prior vaccinations. The patient developed a significant rash and fever within 21 days of vaccine administration. No medical attention was sought. Subsequently the patient recovered.
Patient developed vision changes, dizziness, and right sided weakness after receiving 1st dose of vaccine. Patients BP was measured at 230/118, HR: 58, pOx: 99% on RA. Patient determined to be experiencing hypertensive emergency and emergency services were called in order to r/o possible stroke.
the only thing was the sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (the only thing was the sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ML20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (the only thing was the sore arm). At the time of the report, PAIN IN EXTREMITY (the only thing was the sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Treatment details were not provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-034443 (Patient Link).   Reporter did not allow further contact
The day after the vaccination, patient experienced dizziness with a mild headache. The second and third day following the vaccination patient experienced more severe headache, heavy sweating, and noticed redness and bumps on her forehead. On 8/2/18 patient presented at doctor's office with swollen right nodule on throat, dizziness, redness with itching of the face/forehead/scalp, and swollen eyelids. Prescriber did not conduct any blood work or diagnostic tests but informed patient she had Shingles and prescribed VALTREX 1 gram to be taken one tablet three times daily for 7 days.
This spontaneous report as received via communication agency from online articles covered by several local outlets and TV channels refers to a 2 year old male patient, who participated in program providing regular childhood vaccines for uninsured kids. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, between July 2014 and June 2015 (also reported as between October 2014 and June 2015), the patient was vaccinated with "a high dose" (also reported as an "excessive dose", "double dose") of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). Although it was stated that GARDASIL administration to someone of tender years could present a problem with regard to neurological development (also reported as "the child might be at risk of neurological damage", "might suffer neurological effects from receiving the excessive dose"), the effect of faulty vaccination was not yet known at the time of the report and no such condition was reported. The child had been subjected to further medical monitoring. This is one of several reports received from the same reporter. Additional information has been requested.
for approx 24 hours:  significant pain in shot arm, fever, aches, chills, migraine/headache.  Next 24-48 hours:  rash on both arms and chest, swollen hands and continued pain in shot arm.
fever above 102, swelling w/pain @ inject site, uncontrolable crying, per mom; seen by MD @ ER given Pediaprofenf or fever & ice packs applied to leg per mom;
Pt recvd vax 17MAR92 & 11 wk following vax exp pain @ inject site that spread down arm & extended into neck & shoulders; stiff neck, ache in lt deltoid muscle area & arthritic pain in lt shoulder;
Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 048B21A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNKNOWN. At the time of the report, HEART RATE INCREASED (Five minutes after receiving the booster dose my heart rate went above 90 and reached 95 / By the time I got to the car the heart rate went up to 120 / Heart rate stayed at 90s for few days now in high 80s) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Heart rate: high (High) Heart rate went above 90 and was at times 120 and it never went below 95.Heart rate was now in the high 80s..
Symptoms: Sore throat Swollen eyes Feverish/chills Headache Burning eyes High heart rate Labored breathing when moving Dizzy/blurred vision Sore arm
I spiked a fever, had chills, and then started feeling pressure in my ears.  The change in my ears and my hearing has not gone away.  It's kinda of like when you get off a plane after flying
No adverse effects were reported; on 11/11/2019 a patient was administered VAQTA 6 weeks after initial dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 30-SEP-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dosage detail, route, strength, lot # and expiration date were not reported) for prophylaxis. On 11-NOV-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S001360, expiration date 06-MAY-2020, but upon internal validation established as 06-MAR-2020, strength: 25/0.5 (unit unknown), dosage detail and route were not reported) for prophylaxis (inappropriate schedule of vaccine administered).  No adverse effects were reported.
No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 29-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided), which was inadvertent reconstituted in expired sterile diluent solution for injection/infusion, 1 dose, lot #T029529, expiration date: 16-APR-2023 (strength was not provided) (expired product administered, product preparation issue). No temperature excursion. No symptoms reported. Sterile diluent supported for 12 months post-expiry.  This is one of several reports from the same reporter.
A fast heartbeat Dizziness and weakness Injection site pain Tiredness Helada che Muscle pain Chilla Joint pain Náusea Feeling unwell SEOLLEIM lymph nodes
Rash beginning 4d after the vaccine: diffuse maculopapular/morbiliform rash spreading from L arm across chest to R arm and down the torso to upper legs
Vaccine was given to the patient and within 15 seconds of receiving the vaccine a seizure like episode happened to the patient, he laid back and shook briefly and was briefly not responding, he was very pale then he woke up and then we chatted with him. He was initially very tired but never had any confusion or any other problems. We had him laying down, gave him some juice and animal crackers and slowly had him raise up on the exam table and then eventually standing up. He was evaluated by the physician again as well.
Vial initially stored on 31-JAN-2022 and then administered on 14-APR-2022; The patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 14-APR-2022) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 1:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022 at 1:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 14-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 14-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  It was reported that HCP did not know that the vials should not be used past 30 days from thawing the vials. The vials were initially stored on 31-Jan-2022 and the thaw expiration date was 02-Mar-2022. It was also reported that the vial did not undergo any temperature excursions and the total doses given were 20 doses of 15 vials used. The patient received  first booster dose.  No treatment information was provided.
Pain and itching at injection site without any visible skin reaction.  Pain and itching worsens at nighttime and OTC diphenhydramine does not lessen.
I got my first vaccination on 12/28/2020 at about 3:00 PM. Around 10:00 that night, I began running a fever of about 103. I took Tylenol, which reduced the fever but didn't eliminate it. I then began having generalized muscle aches from my upper extremities to the rest of my body. The muscle aches lasted about a week. The fever disappeared within 48 hours. I also developed a headache at the same time I developed the fever and body aches, and it lasted until about 9:00 AM on 12/29/2020. I got my second vaccination on 01/22/2021 at about 3:00 PM. At about 10:00 PM that night, I began running a fever of about 103 and developed a headache and muscle aches. This time, the muscle aches were concentrated in my legs; my legs hurt so much, I couldn't even walk to the bathroom. The fever lasted about 3 days, and the headache also lasted about 3 days. The muscle aches extended throughout my lower extremities and lasted about 10 days. I took Tylenol, which helped to some extent. My symptoms were so severe, I was unable to go to work on 01/24/2021. In mid-March, I began having shortness of breath and muscle aches in the lower extremities. I called my Dr., who ordered a CAT scan of my chest and referred me to a cardiologist. The CAT scan showed no abnormalities in the lungs but detected an old fracture in the sternum. The cardiologist did an EKG and blood gas test. He detected a possible pulmonary embolism and gave me a blood thinner, Eliquis, which was effective. Some of my symptoms were relieved, but they weren't completely eliminated. I still have shortness of breath and muscle aches, but they are not as bad as they were before.
Approximately 72 hours after my 2nd Moderna vaccine, I noticed a large , warm, red patch on my left arm slightly below where I believe the injection sight was. At this point it is just painful and not itchy.
Onset of generalized rash and joint pain, 12 days, post vax of MMR vaccine. Pt sought medical care from her private physician.
06/01/2018 - injection site swelling and redness. 06/02/2018 - rash/hives.
SMALL AREA OF REDNESS INITIALLY WHICH GREW TO A LARGE RED INFLAMED AREA AT INJECTION SITE THAT APPEARED ABOUT 3 DAYS AFTER VACCINE ADMINISTRATION. AREA WAS LARGER THAN PALM PRINT. PHARMACIST HAD PATIENT FOLLOWUP WITH DOCTOR IMMEDIATELY. DOCTOR DETERMINED THIS TO BE A LOCALIZED REACTION AND IS HAVING PATIENT APPLY BENADRYL CREAM TO THE SITE.