chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored VAQTA (lot # K008333, expiry date: 10-MAR-2017 or M011116, expiry date: 17-JUN-2017) (dose and route of administration were not reported) and improperly stored GARDASIL 9 (L045711, expiry date: 08-MAY-2017, or M004116, expiry date: 12-OCT-2017, or L011846, expiry date: 16-JUN-2017) (dose and route of administration were not reported), both. No concomitant therapy was reported. Maximum temperature excursion was 22.7 Celsius degree for 3 hours 48 minutes and minimum temperature was 0.2 Celsius degree for 31 hours 1 minute. Time frame and date of excursion were unknown. It was not reported, if data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states he could not sleep the night of injection got up at 3:00am, noticed redness and swelling under his left arm, armpit to elbow. Fever all day 12/07/2005. He saw DR 12/09/2005 and was started on Ketek 400mg 2 QD x 5 days for cellulitis.
Vaccine leaked out while being administered; Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)). On 18-Oct-2021, UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Parent called on-call physician with complaint of child sleeping most of the afternoon and very sedate; call came at 7:07 pm - child was awake and alert at that time with eyes described as very dilated but reactive
pt recv vax 13NOV98 & devel T105 on 15NOV98;presented @ ER  kept over noc for observation x 24hr;motrin & fluids;
inexperienced diffuse aches/pains; chills; sweating; nausea; vomiting; Consumption of additional mild food and water was not tolerated; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 11:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa meds" (unspecified if ongoing), notes: known allergies: Yes, sulfa meds. Concomitant medication(s) included: FEXOFENADINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 14May2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Start date: 21Nov2021), when the patient was 36 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021 11:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "inexperienced diffuse aches/pains"; CHILLS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "sweating"; NAUSEA (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "vomiting"; FOOD INTOLERANCE (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "Consumption of additional mild food and water was not tolerated". Therapeutic measures were taken as a result of pain, chills, hyperhidrosis, nausea, vomiting, food intolerance.  Additional information: Approximately 12 hours after the vaccine, inexperienced diffuse aches/pains, chills, and sweating. Approximately 15 hours after administration, he experienced severe nausea and vomiting. Emesis was not productive. Consumption of additional mild food and water was not tolerated, for up to 27 hours post-vaccine. The patient received acetaminophen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested since vaccination. The patient was administered COVID-19 vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was 21Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain, increased warmth, redness,itching around injection site about 24 hours after receiving the vaccine.
Information has been received from a nurse practitioner concerning a patient (age and gender not reported) who in 1989 was vaccinated with a dose of measles virus vaccine live (manufacturer unknown). It was reported on 06-Jun-2003 that the patient had "received a measles-containing vaccine (type or manufacturer unknown) in 1977 and 1989 and now has a negative titer." Unspecified medical attention was sought. Additional information has been requested.
Breakthrough case admission after 4 vaccines Pfizer 3/16/21 Lot# EM9810;  Pfizer 4/6/21 lot# EM9810;  Pfizer 12/2/21 Lot# 33030BD ; Pfizer 7/26/22 LOt# FP7139
This spontaneous report was received from a pharmacist and refers to an adult patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 20-APR-2017, the patient was vaccinated with the first dose of M-M-R II lot # M034856 with expiration date on 27-JUL-2018. On 09-MAY-2017, 19 days after the first dose, the patient received the second dose of M-M-R II with the same lot number and expiration date. Both doses were reconstituted with sterile diluent (MERCK STERILE DILUENT) lot number M034444 with expiration date on 27-MAR-2019. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
He began to shiver intensely and his lips turned blue. This happened twice during the night. Parents wrapped him in warm blankets and had space heater running which helped. Symptoms resolved Phone calls to ED & clinic decision made to bring him in if anymore symptoms occurred
Patient had swelling on her right biceps. Informed patient to use cold compresses and to use ibuprofen. Also informed patient to keep an eye on the adverse event and to go to urgent care if symptoms develops.
Pt had swelling, redness and pain to the injection site. Pt was advised to apply ice to site and take MOTRIN for pain. Pt advised to call if site gets any worse.
Had itchy throat scratchy voice burning in chest  lightheaded and elevated BP 10 minutes after injection.  Next day pain and left arm and injection site blood pressure remains elevated and lightheadedness Next day still pain in arm  elevated blood pressure  nausea Headache and still have all symptoms 7 days later except pain at injection site
Information has been received from a consumer reporting herself with sulfa drugs allergy and allergic reaction to neomycin who "several days ago", was vaccinated with a first dose of ZOSTAVAX (Merck). The patient had been miserable ever since. She had a severe yeast infection all over her body. No treatment was given for the adverse events. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
This is a spontaneous report from a contactable consumer reporting for himself and from another contactable consumer (patient wife). A 71-year-old male patient received the first single dose of PREVNAR 13 via an unspecified route of administration on 05Feb2015. Relevant medical history included acid reflux for which he took an unspecified medication, high blood cholesterol, atrial fibrillation, osteoarthritis for which he took an unspecified medication, ongoing schizophrenia. Concomitant medications included: GEODON at 40 mg twice a day for schizophrenia, trazodone, REMERON, PRADAXA at 150 mg twice a day for atrial fibrillation, CARDIZEM at 240 mg in the morning for atrial fibrillation, pravastatin for high blood cholesterol, all ongoing. On 05Feb2015, twenty minutes after the vaccination, the patient started to feel cold and to experience chills and he also felt 10 feet tall. The patient was hospitalized due to the event "he felt 10 feet tall" for 12 hours and received treatment for vertigo. No treatment given for events feel cold and chills. The patient added that he had schizophrenia and he did not know if that was why he felt 10 feet tall when he received the vaccination. The patient wife reported that he had lot of blood work during a previous hospitalization but she did not have the printouts of the blood test results and that the hospital could provide that information. Patient recovered from all the events on an unknown date. Follow up (11Mar2015): New information received from the same contactable consumer includes: seriousness, concomitant details, outcomes updated.
local rxn DTp lt deltoid 4x4cm swelling, warmth, erythema lasted 5-6 days;tx cold compresses;no temp;
This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients was vaccinated with improperly stored PNEUMOVAX 23 lot # N010105 with expiry: 15-NOV-2018 and lot# N010106 with expiry: 15-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 47 F to 77 F for a duration of 45 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 47 F to 77 F for a duration of 2 hours and 30 minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Sender's Comments: US-009507513-1709USA001357.
After 4 hours pain in shoulder which increased over time and radiated up to back of head. Physician diagnosed neuritis.
5- 10 minutes after administration of Tdap and MCV4 Vaccine patient complained of feeling flushed and hot. She was given a cool cloth for her face. O2 Sat was 99%, Heart Rate was 88, BP 102/62, Resp. 16.  She was also given sprite to drink, her mother reported that she did not eat breakfast this morning prior to vaccinations. After 10 -15 minutes she reported feeling better. She was alert and talking able to follow directions throughout the incident. Called mother at 11:20 AM and she verbalized that she ate a biscuit and has been fine since the incident.  Informed her to call if any further issues arise or seek medical attention.
Information has been received from a health professional concerning a 12 month old pt who on 30Jun05 was vaccinated with a dose of varicella virus vaccine live (lot549738/0120R). Subsequently the pt experienced breakthrough. On 13Jul05 the child developed a rash with white centers. Unspecified medical attention was sought. Treatment included calamine lotion, baking soda baths and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
1st covid booster, phizer,  noted my ankles swell every day since booster, I get sob,  tried to waltz with husband, got very short of breath, purse breathing to my seat, never ever happened before, get sob woth any activity.  Also, had a rifgt shoulder rotator cuff tear.  All in January and symptoms since.
After the vaccine my wife started to have irregular thyroid behavior- what was her normal dose became an excessive amount and she developed a cluster of symptoms consistent with hyperthyroidism- weight loss, tremors, decreased respiration capacity, -   The Dr. had assumed that she was simply taking too much Synthroid and reduced the dose, but she had been on that amount (25mcg) for years- the thyroid doesn't normally start to work again (cancer, and a few other exceptions, but she had a scan and that's not an issue) - Since it through off her respiratory rate, the pulmonologist assumed it was asthma or COPD and gave her inhaled steroids- but they didn't change her peak breathing capacity-
Pneumococcal polysaccharide vaccine 930am 22Sept10. Extreme dizziness on awakening 8am 23Sept10. Headache unable to stand - slept 24 hours - drank water. Unstable - hard to sit or stand - slept most of day 24Sept10. Walk with cane morning - walk unaided & swim afternoon 25Sept. Tired but able to function normally 26Sep10 (no fever throughout).
I had received 3 doses of the Pfizer COVID-19 shot.  On Aug 5, I had my first 2 doses of Emgality (loading dose), one in each front-of-thigh.  (Emgality is also called Galcanezumab, and is a monoclonal antibody medication used to prevent migraines.)  No allergic reaction, no problems. On Sept 5, I had my next monthly dose of Emgality, in my abdominal area.  The next day, I develed mild urticaria, very itchy, at the injection site.  The final size of the pink swollen area was an oval about 1" by 2".  On Oct 3, I spoke to my neurologist's P.A., and she advised taking Benadryl, which I did. The itching finally stopped after almost a month.  On October 5, I had my next dose of Emgality, in my left front thigh. (Cont)
Day 1 post vaccine: Headache, fatigue, rounds of vomiting, fever, stomach pain, acid reflux Day 2 post vaccine: Fever, fatigue
High fever, extreme headache, chills, body aches, tiredness, fatigue, soreness at injection site
Muscle pain in left arm continuing weeks after the shot. It is especially painful after sleeping, even when sleeping on my back or opposite side. It can be difficult to even lift my arm or pickup objects on that side at times. I don't take pain relievers regularly so I don't know if that would solve the problem or not.
Four hours after the vaccination I experienced deep heavy sharp pain with weakness within my left shoulder and surrounding area, inability to freely move my left arm without sharp and intense pain. These symptoms have continued since 3-31-2021. I made an appointment with my primary care physician who is not able to see me until April 8, 2021. On Saturday 04-03-2021, I visited a local walk-in clinic for advice on how to avoid making my shoulder worse by keeping it too still or trying to stretch it out. After being examined, I was prescribed prednisone tablets to take for five days, and a gentle exercise to do to help shoulder flexibility.
Patient developed L sided facial tingling and left sided Headache about 6 hours after injection.  No facial droop noted, neuro exam by MD was normal.   Patient was given Benadryl 25mg PO x one dose, and improved within 30 mins.  Discharged home in NAD
Pt received the 2nd dose of the SHINGRIX on 7/23/18. Pt called on 7/24/18 to report she was having fatigue, aching, shivering, muscle pain, mild diarrhea and a low grade fever. This started the night of the vaccine. She did not have any of these side effects with the first shot in the series. I called Glaxo and was advised that these side effects have been reported more by patients after they receive the 2nd dose of the SHINGRIX.
Starting 06/22/2022, I tested positive for COVID-19. I had some sniffles but that's about it. I called my doctor the next day to see next steps. I was starting to feel poorly: nasal congestion and cough. On Friday 06/24/2022, I spoke to the doctor and they decided to prescribe me PAXLOVID. I have taken the full regimen as of this morning (06/29/2022) and I feel almost no symptoms. I am experiencing some mild runny nose intermittently but my fatigue has gone away.
Redness and swelling of left thigh surrounding injection site.  ER prescribed Augmentin.  Seen in office on 08/26.  Redness decreasing and some swelling present.
lymphadenia,fever 101.8R;body rash over all;loss appetite;diarrhea;
mild stiffness at the injection site; nasal bridge swollen and painful; This spontaneous case was reported by a consumer and describes the occurrence of NASAL SEPTUM DISORDER (nasal bridge swollen and painful) and VACCINATION SITE SWELLING (mild stiffness at the injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NASAL SEPTUM DISORDER (nasal bridge swollen and painful). On an unknown date, the patient experienced VACCINATION SITE SWELLING (mild stiffness at the injection site). At the time of the report, NASAL SEPTUM DISORDER (nasal bridge swollen and painful) outcome was unknown and VACCINATION SITE SWELLING (mild stiffness at the injection site) had resolved.            He denied any other issues after receiving the vaccine and reports he was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Narrative was updated
Arm was swollen and hurt when the shot was given. Signs and symptoms were consistent with warnings with the first injection.   . A week after injection. Area swelled more than the first week. Auxiliary pain in left shoulder still prominent. Experienced more severe symptoms such as headaches, tiredness, and joint aches. Area of injection was hot to the touch, extremely itchy when it was swollen. Slightly elevated temperature for the last two weeks.
This solicited report was received from a consumer enrolled in a patient support program and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (lot #, expiration date, dosage and route of administration were not reported) for prophylaxis. The reporter stated that there had been a lot of people that had bad reactions (onset date unknown), some of them, the reporter knew personally as well as several people who had passed out after receiving it. The outcome of the events was not reported. The relatedness between the vaccination with GARDASIL and the events was not reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA001363.
Information has been received from a certified nurse practitioner referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (Lot number L043213, expiration date: 28-AUG-2017). The vaccines were exposure to 1 Celsius degree 2 hours. Data logger was involved. Additional information has been requested.
ADMITTED TO HOSPITAL 6/11/2021 WITH RESPIRATORY DISTRESS, SEVERE SOB EXPIRED 6/12/2021 HX. OF METASTATIC LUNG CANCER AND LEUKEMIA
3 days after second rabies vaccine, he went to doctor to report water eyes, stomach upset, headache.
Of my mouth to the chin started to..hello..hello..my chin started to swell; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, A patient stated, got the first shot. A week later noticed the left side of my mouth to the chin started to swell. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Patient experienced metallic taste in mouth with burning sensation. The patients lips "started burning for hours." She stated this started three days after the first Pfizer dose and has occurred twice for three days the past two weeks. Patients symptoms are currently getting better and rated the pain as a 2/10. Patient has not treated this adverse event as it is sporadic and treatment is unknown.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 83 years and 2 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code- 80777-0273-99. No treatment medication was provided.
Face went numb then collapsed on kitchen floor but did not lose consciousness.  Slept for biggest part of that day.  Have been experiencing dizziness, eye pain, severe headache, nausea, chills and leg/ muscle weakness ever since.  Consulted physician and pharmacy where I got the shot. They told me to rest and come in if symptoms worsened or did not get better.  Will go in to my physician today.  This was my first reaction to the flu vaccine and my 3rd time receiving it.
Patient states on 8/3/18 she acquired an eyelid infection. That was later diagnosed by ophthalmologist on 8/5/18.
Severe vertigo onset 12 hours following injection. Nausea and mild headache. Symptoms disappeared gradually over  18 hour period.
Fever 38.1 on 1/26/21. Instructed to call if fever did not resolve in 48 hours.