chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from healthcare professional on 29 September 2013. A 59-year-old female patient whose concomitant medications were not reported, had received intramuscular dose of FLUZONE HD, batch number: U4764AA (dose number was unknown) in right deltoid on 29 September 2013. The patient has no known allergies and illness at the time of vaccination was unknown. It was reported that on 29 September, the patient was given HD by mistake. Thus there was vaccine overdose and experienced 1 inch red swollen area, hot to touch with rash around injection site on right deltoid, chest tightness and dizzy feeling. The patient's corrective treatment and laboratory investigations were not reported.  At the time of this report, the outcome was not recovered. Documents held by sender:  none
My period is currently 5 days late, with no chance of pregnancy. I am showing all signs of a period except the bleeding. My periods have always been regular on a 28th day cycle with  period lasting 5 days. I have body aches, bloating, headache, fatigue, normal period  moodiness but no bleeding.
Autonomic nervous system imbalance; Orthostatic intolerance; dizziness; headache; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced autonomic nervous system imbalance orthostatic intolerance, dizziness, and headache. Reported date of injury was unspecified date in 2007. The outcome of the event was not reported. The causality assessment was considered as related by the lawyer.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Nurse stated that a teardrop amount of vaccine dribbled down the patients arm after giving him the dose using a vanish point syringe which was harder than normal to depress the plunger. The amount is not known but not more than half of the total dose so it was not recommended for the patient to receive any additional vaccine. Patient was told they may be able to get an antibody titer later on if needed from his primary care.
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
This spontaneous report as received from a health care worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. The reporter stated that on an unknown date the patient had positive titer for mumps and rubella but negative titer for measles. The reporter was unsure if the positive and negative titers were due to the patient having M-M-R II in the past or just due to a natural disease. The outcome of patient was negative for measles was unknown. The causal relationship was not reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
patient was given PNEUMOVAX23 that was recalled; Vaccine was incorrectly stored/Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 22-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient presented back into office with mother and grandmother after receiving his proquad and kinrix vaccines. No local reaction noted. Patient presented with severe bilateral eye swelling, raspy voice, itchy throat, minimal cough. Vitals: O2 sat:100%, HR 77, temp 97.6 Epipen Jr administered x 1 in his left thigh IM at 12:49 pm. Verbal order given by NP .
Swelling in face started the day after vaccine administration and continues, heart palpations verified by FDA approved Heartbeats app, paid version, started about a week ago and chest pain started 3 days ago (pain and pressure in chest radiating downleft arm, behind left shoulder blade and in left jaw)
Pt who was exposed to her sister who was vaccinated with one dose of varicella virus vaccine live developed a vesicular rash consistent with chickenpox. The pt was noted as having 30-40 lesions on her trunk and palate. Physician stated that the chickenpox is going around the school and pt may have been potentially exposed to wild type varicella virus. A VZV specimen was positive for VZV and found to be wild type virus and not vaccine related.
Vomiting, rash on face, crying, fever and acts as if his stomach is cramping.
Intern administered dose 1 of vaccine in patient's left arm. at 6:45pm.  Within 2 minutes patient's eyes started rolling in the   back of his head,his face turned pale, started clenching his teeth and making guttural noises.  Mother supported patient's head and neck and RPh was called to the immunization room. Patient was placed in supine position.  At this time patient had come to but was still looking pale and confused.  Offer to call 911 was declined at 6:50pm.  Patient's blood pressure was checked-94/58 at 6:50pm.   A cold compress was applied to patient and water was offered.  Blood pressure was retaken and was 97/68 6:55pm.  EpiPen and offer to call 911 was again denied by mother. The color started returning to his face, atient was monitored and blood pressure was taken again-100/68 at 7:08pm.  At this time he was able to sit up in a chair.  He was then able to walk to  our waiting  room with assistance and was offered snacks.  At 7:20pm blood pressure was rechecked 100/68 and patient and mother were escorted out of our pharmacy.
23JUN93 recvd immun 23JUN93 10AM, 2PM; pt awake from nap w/swelling to lt knee, unable to walk; c/o pain;
Breakthrough case admission after 4 vaccines Moderna 1/21/21 Lot# 029L20A;  2/18/21 Moderna Lot# 023M20A;  11/4/21 Unknown Lot# 077C21B;  Moderna 1/12/23 Lot# 043H22A
Chills - started 6 hours after shot, lasted 12 hours Headache- same Muscle ache-same
sore throat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Systemic sclerosis, Scleroderma, Bronchiectasis, Hypogammaglobulinemia (low IGG to bind to primary antibodies), Chronic kidney disease stage 3 (50% Kidney function) and Heart disease, unspecified.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  Patient have a connective tissue disease, features of lupus.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
BREAKTHROUGH COVID: PT FULLY VACCINATED 19-year-old woman with RECENT DX OF COVID 19 7/1/22. Convulsive syncope in the setting of COVID/alcohol use/marijuana use/increased stress.  Differential diagnosis includes first-time seizure but less likely given the description of events and normal EEG. no PMH that presented for evaluation of back-to-back syncope and presyncopal events, one of them with convulsive component, in the setting of COVID/alcohol use/marijuana use/increased stress.  Pt reported resent stressful events with euthanized dog yesterday. No epilepsy risk factors - had two seizure-type events at age 7 but both of them were provoked after painful stimuli, with no abnormalities and no antiseizure medications prescribed (not clearly epileptiform).
Upper lip swelling. Rapid heart beat. Rash locally & local swelling & tenderness. Last 36 hours.
This case involves an unknown age and unknown gender patient who experienced got sick from them while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation). On an unknown date the patient developed a non-serious event "got sick from them (illness)" (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I have had mine and got sick from them I am getting booster monday and not looking forward to it." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got sick from them). At time of reporting, the outcome was Unknown for the event got sick from them.
one of 2 children who recv. dtp/hibtiter devel. a macular type rash beginning at one of inject sites and spreading to the rest of body.  unclear which vax given at site of origin.
In order to recieve the vaccination pt must have been 50+ Years old, however it was discovered that the patient was 49 years old at the time of vaccination. PT did not report any adverse advents or needing to seek medical treatment. Pt reports not issues, other then recieveing vaccination 7 months early
Major joint pain fingers, toes, etc. Could not eat eggs or chicken based food. IBS. Fatigue. Hot flashes. Pain from injection site up arm to back of head. Heart palpitations/nausea.
loss of consciousness; started breathing really hard; does not remember anything; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criterion medically significant), RESPIRATORY RATE INCREASED (started breathing really hard) and AMNESIA (does not remember anything). At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness), RESPIRATORY RATE INCREASED (started breathing really hard) and AMNESIA (does not remember anything) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment details provided for these events.
patient had 3rd covid vaccine at nursing home provided by Pharmacy. on 8/30/21. ER record from 8/31/21 describe the following: pt with altered mental status shortly after receiveing 3rd covid vaccine " notacting herself". approx 20 hours later becomes  more difficult to arouse. patient admitted to hospital. dx. UTI, slightly dehydrated O2 sata = 98%. Reported to be found at NH obtunded. 9/3/21 discharged back to SNF.   COVID VACCINES:  1/25/21: MODERNA Lot 041L20A 2/22/21 MODERNA Lot 041L20A
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-059975.
Case number PHEH2014US003808 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow up report received from the pharmacist on 24 MAR 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly into his right deltoid on 23 NOV 2013 at 15:14. No adverse event was reported following this administration error. NO additional information was available.     Follow report received from the pharmacist on 24 MAR 2014: The anatomical site, date and time of vaccination were updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child".
COVID vaccination in mid December.  Started developed heart failure symptoms in mid January.  Echo in early Feb 2022 showed a significant drop in ejection fraction to 30% from previous echos showing normal EF.
She was vaccinated with johnson and johnson product on 4/11/21.  On 4/11/21, developed fatigue.  She reports on 4/12/21 she developed paresthesias in her B feet, and these spread to involve her B hands and forearms on 4/13/21.  She did also within 24 hrs of vaccination develop fatigue, lightheadedness, headache,and "brain fog".  She also feels "jittery" and "figety" like it is hard to sit still.  She has some improvement in paresthesias from 4/13-4/16, but recurrence in this symptom on 4/17.  Lightheadedness also worsened on 4/17, especially with physical activities or bending over/position changes.
OUT OF BREATH, SHORTNESS OF BREATH; HEADACHES; FELT DIZZY,FELT LIKE SHE WAS GOING TO PASS OUT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, temporomandibular joint disorder, deviated septum, and jaw pain, and concurrent conditions included low blood pressure (110/50), tooth problems, penicillin allergy, celery and avocado allergy, and allergy to animal products. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced felt dizzy, felt like she was going to pass out. On 06-APR-2021, the subject experienced out of breath, shortness of breath. On 06-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/50 (low). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 30-JUN-2021, was recovering from felt dizzy, felt like she was going to pass out, and had not recovered from out of breath, shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Weight of the patient was given as 160.6.  No concomitant medications were reported.  It was reported that the patient was vaccinated with vaccine after the 30 days beyond use date. The date the vial was initially stored in the refrigerator was 10-Jun-2022. It was also reported that the vial did not undergo any temperature excursions. Reportedly, no adverse reactions were reported.  No treatment information was provided by the reporter.
26 hr after receiving varicella vaccine at our clinic pt. c/o Red hive like reaction at injections site-very itchy, given oral Benadryl-calamine to hive like rash with some relief-to continue this until gone or if worse refer to private provider. 5-22-07 parent reports 1 hive like rash-itchy remains at injection site
pt recvd vax & devel swollen L deltoid area w/ induration & cellulitis;
Was given a 3rd shot of Shingrix. First 2 completed 2018. 3rd one was not needed, No adverse event reported from extra dose
covid vaccine breakthrough case  dose 1 Moderna 2/26/21 024M20A dose 2 Moderna 3/26/21 030A21A dose 3 Moderna 10/22/21 046C21A
Shingle; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: In 2018, within a few days after receiving Shingrix, the patient within the reporter's clinic experienced a case of shingles. The reporter did not consent to follow up. Additional supportive information: This case had been linked with case US2022AMR077334, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR077334:Same reporter. Patient 1 of 2.
N/A - LOT# WAS DISCOVERED TO BE EXPIRED AFTER VACCINE ADMINISTRATION.
SUSPECTED VACCINE FAILURE; SUSPECTED COVID 19; ALLERGY SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with additional information received  on 20-Jul-2021. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Patient had concomitant therapy of other therapeutic products unspecified. Patient thought that he had allergy symptoms which started on 14-JUL-2021. He also had hernia surgery on 16-JUL-2021. He lost taste and smell on 19-JUL-2021. On 19-JUL-2021, he was tested was positive for COVID.  Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Patient had suspected clinical vaccination failure and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and allergy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210741495. This report was associated with product quality complaint: 90000186465.     .; Sender's Comments: 20210742023-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine 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
Late in the evening post vax, the pt's arm became sore and swollen. By morning the swelling doubled in size. Very limited range of motion without discomfort. On 5/9, the pt had to leave work due to severe nausea, dizziness, palpitations, and limited arm movement. Pt was seen by a dr and dx with a severe reaction. Benadryl and Motrin taken per dr's request. Pt was also seen in the ER on 5/11 with persistent nausea and dizziness and continued limited range of motion. Her arm is sore all day; worse in am often not being used all night. On 5/15, the pt's palpitations stopped. On 5/16, the pt had nausea with dry heaves and lightheadness. On 5/18, pt developed sore, swollen glands in her neck. On 5/19, the swollen glands were worse, now including swelling under the tongue on the left side. Evaluated by dr due to inability to eat. Tongue was hard to manipulate without pain. Pt continues with symptoms.
Local swelling and pain approximately 4-5 inches distal to deltoid vaccination site, resolved with icing and ibuprofen within another 72 hours.
Immediate nauseousness, dizziness after vaccination. Nausea lasted approx. 20 min. BP 55/32 pulse 60. Lied ptn. on floor, elevated feet, rechecked BP every 5-10 min. until pt. felt signif. better. BP (2nd) 76/52. (3rd) 80/53. Ptn. now seated. BP 73/55. Ptn. left store 12:45p. Called at 15:45 pm. tingly hands before lying down.
Shot was given on 06/12/00 at 8:30 AM and reports within 1 1/2 hours, the patient became hoarse and this lasted 1 hour. He denies any other problems, no rash. Telephone call to MD and told to give shot and observe. Telephone call to client on 07/19/00 at 12:00. Client reports no problems.
The day following the injection (day 2): extreme fatigue (slept 18 hours in a row), muscle aches, headache, lightheadedness Days 3-6:  headache, muscle aches, rash, mild fatigue
Slight swelling and redness at site of injection. Arm soreness radiating to shoulder - pc patient.