chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown demographics. Patients medical history and current condition was not reported. On an unspecified dates since 13-NOV-2014, unspecified patients were vaccinated with improperly stored VAQTA (strength and dose not reported). No adverse events reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 15:00 as dose 5 (booster), single (Lot number: GJ3274) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6298), in left arm, on 27Mar2021 at 11:00 as dose 2, single (Lot number: ER8732), in right arm, on 13Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 13Jul2022 at 15:00 as dose 4 (booster), single (Lot number: FP7135), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2017, stop date: 18May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204080 same reporter/patient, different drug/event.;
A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night.  24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.
Initial report was received from a health care professional on 16 March 2011. An unidentified child who was behind on immunizations had received PENTACEL (lot number, route, site and date of administration not reported) and unspecified amount of time later developed a local reaction. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Rec'd DTP/OPV 30JAN91 developed temp 102 po, redness, swollen arm; hot, swollen, rash;
acute activity limiting vertigo gradually lessening after 4 days, now intermittent with intermittent brief episodes
Patient was found this afternoon cold and not breathing.  His resuscitation was not successful.  Autopsy report received stated COD was SIDS.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning an eight-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 08-Jan-2012. On 09-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 24-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events and she also said the person that administered FLUMIST to this patient.
First day of the shot immediately I had a headache and my stomach started to hurt really bad. My arm hurt and swelled up for a few days with a large red bump. After a few days the bump went away. Im still having headaches, ive had diarrhea from day 1. I already struggle with my bowels and go to the bathroom way to much already and after given the vaccine those next days and still days continuing after I cant stay out of the bathroom. In 6 hours i had over 7 to 10 bowel movements and I hadnt ate a thing. As i thought I was getting better I woke uo the next day with my throat swelled up and i was all congested like a cold my body is very tired very sore a very light cough formed as well too my breathing is ok so far, my body on the inside feels like its on fire but im cold on the outside, one minute i was cold them im burning up. Its making me very overwhelmed and my nerves are all over the place.
Within 4 minutes of receiving MMR, onset respiratory distress, wheezing, EPIPEN administered to right thigh. Sent to ER for resp. treatment and ICU for observation.
PATIENT FAINTED AT APPROXIMATELY 3:25 PM. ASKED PATEINT HIS NAME, DATE OF BIRTH, AND IF HE IS FEELING WELL? PATIENT STATES HE FEELS MUCH BETTER AND STAES HE WOULD LIKE TO SIT FOR 30 MINUTES. PATIENT WAS OFFERED TO CALL THE AMBULANCE HE DENIED. AT 3:45 PM PATIENT STARTED FEELING NAUSEOUS AND TURNED PALE WITH SWEAT, EMERGENCY SERVICES WAS CALLED  EMERGENCY SERVICES CAME IN 5 MINUTES - PATIENT WAS CHECKED AND REMAINED AT PHARMACY. PT'S SISTER PICKED HIM UP AT 5PM, PATIENT WAS FULLY ALERT AND ORIENTED TO TIME AND PERSON.
this is one of four patients who devel fever,redness & tenderness @ the inj site;no further details known @ present;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: The patient fainted appx 5 minutes after the injection. 911 was called.
This study case was received from the investigator in a trial on 18 July 2014. A male subject with a history of receiving ACAM2000 in May 2008 had received on 19 June 2014 the following concomitant vaccines: Typhoid vaccine and Anthrax vaccines (manufacturer, lot numbers, routes and sites of administration not reported) and 25 days later experienced a positive rapid troponin I. The subject had a normal lab troponin and an ECG that "appears normal". The subject was asymptomatic and recovered on the same day 14 July 2014 without treatment. The subject was in the control group and did not receive the study vaccine during the study period. According to the investigator, no information was expected to become available. The investigator considered the event of positive rapid Troponin I to be mild in severity, remotely related and an other important medical event. Documents held by sender: none.
Swelling, red (size of an orange) RT deltoid area of injection. Black and blue size of two fingers. No treatment needed. Will follow up with primary MD to check on local  allergic reaction?
Info has been received from a health professional concerning a 56 year old female pt who on 12/7/02 was vaccinated with the 1st dose in a series of Hep-B vaccine. On 12/10/02, the pt presented to her internist with Bell's Palsy. It was noted that the pt was being treated with corticosteroids. Follow up non 03/09/04: "On the morning of 12/10/02, approximately 72 hours after vaccination, the pt presented to the internist with Bell's Palsy.  The pt was referred to a neurologist and was subsequently treated with Prednisone and physical therapy.  It was unknown if the pt underwent any testing. At the time of this report, the pt was "improved" but had not yet recovered from the Bell's palsy. The pt was still being followed.  Bell's palsy was considered to be disabling. Additional information has been requested."
Pt start med having symptoms a few hours after the vaccine was administered. She experienced fever up to 102 degrees F, joint pain, shivers, chills, fatigue, loss of appetite. She says she was unable to leave her bed the entire time she had the adverse events. Her symptoms lasted about 24 hours.
Started with hives at the waistline and moved around the body for ~2 weeks (behind the ears, back of scalp, butt, etc.). Hives would also appear with pressure to the skin (i.e. sitting on a chair, hives on butt; scratching arm, hives on arm;) After the hives died down, started to have symptoms that appear to mimic dermatographia. To this day (almost 12 weeks later), I will get red lines on my skin (not elevated) if I scratch myself. If I wear gloves, the redness appears on my wrists, etc.
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered.   Information on the Lot/batch number has been requested.
patient has low Hepatitis B antibody titers after receiving unspecified Hepatitis B vaccine; This spontaneous report was received from a pharmacist, referring to a 25-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose, strength, lot# and expiration date were not provided) intramuscular for prophylaxis.  On an unknown date, the patient had low Hepatitis B antibody titers. The patient sought medical attention. The patient received revaccination for treatment. The outcome of the event was reported as not recovered.   The causality assessment between the event and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was not provided.
administered via intramusclar route; no adverse  event; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. The patient's concomitant medication included sterile diluent. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R029517, expiry date: 14-OCT-2020) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031636, expiry date: 01-NOV-2020) (dose details unknown) for prophylaxis. Both the vaccines were administered via intramuscular route instead of subcutaneous route (incorrect route of product administration). No adverse event reported. measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type of rHA involved.
Information has been received from a health professional concerning a patient (17 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Pt received vaccines Trihibit, Hep-A, Prevnar on 5/9/06. Seen in ER 5/16/06, mother noticed swelling 5/14/06 of right thigh and took child to ER 2 days later. was on Augmentin since then but draining. Admitted today.
Patient received first dose on 26-Mar-2021, second dose on 09-Apr-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Mar-2021, second dose on 09-Apr-2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included ADHD, Anxiety, Developmental delay and Hypotension. Concomitant products included ESCITALOPRAM and TRAZODONE for Anxiety, PRAZOSIN for Nightmares.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Mar-2021, second dose on 09-Apr-2021). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Mar-2021, second dose on 09-Apr-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. Patient had PTD. Patient had PTSA related nightmares for which she takes Prazosin.   This case was linked to MOD-2022-472187 (Patient Link).
Day 2-4 afterward I had lightning like pains in my head (sides) and a dull headache.  On 1/16 the injection site started itching terribly and kept me up at night, on 1/17 I had a rash on my upper left chest and torso and at the injection site.  The rash has continued just around the injection site .
4 month old received Fluarix QIV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old received Fluarix QIV).  The outcome of the inappropriate age at vaccine administration 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: 04-OCT-2023 The reporter reported the administration of Fluarix QIV to a 4 month old patient which led to inappropriate age at vaccine administration. The Healthcare professional asked for expected side effects and safety information regarding the situation. The reporter did not provide patient information (gender, patient initials) nor information regarding the Fluarix QIV dose given (lot number expiration date). The reporter consented to follow up.
Patient had injection site reaction about the size of the palm of your hand in a circle around the injection site on her arm. It was very red and itchy.
Arm felt heavy after injection and began sweating profusely and feeling lightheaded within 2 minutes of injection.
arm is sore where I received a Shingrix vaccine; Discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and injection site discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient received Shingrix and experienced pain in arm and injection site discomfort. The patient inquired about use of ice or heat to help alleviate the discomfort. The information regarding consent to follow up was not reported. No further information was available.
pt admitted to hospital after 2 wks at home with SOB (which is increasing) and flu-like sx; poor prognosis; DNR/DNI/limited interventions; O2 supplementation; decadron, ABX, O2 need increased requiring BiPAP; pt's condition worsened and he passed away in the hospital
10/18- slight cough and sore throat. 10/19- cough worsens, slight headache with developing body aches. 10/20- fever in am (100.8 F), chills and body aches, severe headache and vomiting.  Visit to ER.  10/21 and 10/22- improvement with headache, still coughing and body aches and weakness.  Still slight fever without medication. Developing nasal symptoms. 10/23- dry cough increases, slight sore throat and eventual complete laryngitis. 10/24- continued laryngitis, green mucousy sinus discharge. That's where I am at today.
This spontaneous report as received from a registered nurse refers to a 9 year old patient. On 28-AUG-2001, the patient received first dose of MMR II (lot number, expiry date, dose and route of administration were not reported) and 16-JUN-2008 the patient was vaccinated with the second dose of MMR II (lot number, expiry date, dose and route of administration were not reported). On 15-MAY-2003, patient received one dose of VARIVAX (lot number, expiry date, dose and route of administration were not reported). No concomitant therapies were reported. The reporting nurse could not identify an adverse event when the two doses of MMR II and the one dose of VARIVAX were administered. But it was noted in the patient's chart that the patient had a critical reaction to porcine gelatin on 30-OCT-2009. The reporting nurse has no information at the time of the call on what the critical reaction was or what caused the critical reaction. The outcome of critical reaction to porcine gelatin was recovered. The causality of the events in relation to the two doses of MMR II and the one dose of VARIVAX was unknown. Additional information has been requested.
Really sick for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick for 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Overweight.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ILLNESS (Really sick for 3 days). In October 2021, ILLNESS (Really sick for 3 days) had resolved.            Patient had Medical history Lupus Concomitant information was not provided It was reported that the patient experienced sickness right after getting the booster shot. Treatment information was not provided.   This case was linked to MOD-2021-358530 (Patient Link).
cherry red blot(patch) that is like a shape of boomerang 7 inches away from Injection site.; Temperature increased; Increased heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate), RASH (cherry red blot(patch) that is like a shape of boomerang 7 inches away from Injection site.) and PYREXIA (Temperature increased) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (Increased heart rate) and PYREXIA (Temperature increased). On 19-Feb-2021, the patient experienced RASH (cherry red blot(patch) that is like a shape of boomerang 7 inches away from Injection site.). On 18-Feb-2021, HEART RATE INCREASED (Increased heart rate) and PYREXIA (Temperature increased) had resolved. At the time of the report, RASH (cherry red blot(patch) that is like a shape of boomerang 7 inches away from Injection site.) had not resolved.            Treatment information includes Acetaminophen (2 tablet).   Concomitant product use was not provided.   Action taken with the mRNA-1273 in response to event not applicable.    Reporter did not allow further contact
Muscle pull; A spontaneous report was received from a physician, concerning an 84-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pull.   The patient's medical history was not provided.  Concomitant medications included blood thinners.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, on the same day of vaccine administration, the patient experienced severe pain in the arm, shoulder, and front of his chest into his back. He was taken to the emergency room (ER) where he was diagnosed with a muscle pull and was admitted to the hospital for one night. Treatment for the event included 500mg paracetamol. At the time of the report, the patient was still experiencing symptoms.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, muscle pull, was considered not resolved.; Reporter's Comments: Company comment: This case concerns an 84-year-old male patient, who experienced unexpected serious event of muscle pull. The event occurred 1 days after the administration of the first and only dose of the Moderna's COVID-19 vaccine (mRNA-1273). Based on the known cause for muscle pull which is mostly due to an overstretched or torn muscle, the event is assessed as unlikely related to mRNA-1273 administration.
Ringing in ears 1 week after 1st Moderna COVID-19 vaccination shot. 9 weeks it appears ringing is now in left ear only. Note that the shot (both shots) were on left arm.
Patient states that he has history of syncope episode with first Prizer Covid19 vaccine. Patient had episode of syncope 5 minutes after injection for approximately 10 seconds. Ammonia salts were used immediately and patient was immediately alert after use. Patient was offered medical emergency assistance but declined. Patient was advised to stay full 30 minutes and seek further emergency medical advice if needed after being monitored. Patient was advised to wait with legs and feet elevated. Patient complied with all request besides further emergency medical treatment at this time. Patient denied any sigs or symptoms of throat tightness, trouble breathing, hives, or itching. Patients pulse was monitored continuously throughout monitoring. Pulse immediately after syncompe was 45. Pulse gradually rose to 75-80 prior to leaving. Patient blood pressure was checked prior to leaving and WNL. Patient was alert and oriented x 4 prior to leaving. Patient chose to leave after the 30 minute monitoring period. Patient was accompanied by 1 friend/family member the entire encounter and left with this person as well.