chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his wife's relative got a fever of 107F after the second dose of the Pfizer COVID-19 vaccine.; This is a spontaneous report from a non-contactable consumer received from a Pfizer-sponsored program via medical information team. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his wife's relative got a fever of 107 F after the second dose of the pfizer COVID-19 vaccine on an unspecified date. The reporter would like to know if Pfizer can provide any guarantee or anything that will say that the Pfizer COVID-19 vaccine is safe for the next 10 years and wanted to know that how long this vaccine immunity last. The reporter also stated that how would he know that the vaccine is not going to cause cancer and how would he know that it will not cause any long term side effects and added if he's going to be dead if he takes the vaccine. The reporter also wanted to know that if it's normal to have a fever of 107 F after receiving the second dose of the Pfizer COVID-19 vaccine and also asked is Pfizer mandating its employees to get the Pfizer COVID-19 vaccine. The reporter also stated that how could they say that the vaccine was safe. They have drugs out there for 10 years on the market and they pull over, change the formula and put it back on the market (referring to ranitidine). The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 12cm diameter region of blotchy erythema with induration (minimal induration at vaccine site only) - + itchy
Reporting administration error, no side effects reported. Patient was given a second Moderna Bivalent Booster in error  34 days after receiving first Moderna Bivalent Booster.
ACUTE NON ST ELEVATION MI 3/24/2023 HEMODIALYSIS CATHETER COMPLICATION, INIT ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/24/2023 HEMODIALYSIS CATHETER COMPLICATION, INIT TRANSIENT HYPOTENSION 4/10/2023 HEMODIALYSIS CATHETER COMPLICATION, INIT ACUTE RESPIRATORY FAILURE 3/24/2023 HEMODIALYSIS CATHETER COMPLICATION, INIT
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/9/21.  No adverse events have been reported by patient.   Error discovered on 8/16/21.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and CALCIUM for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.       Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Diarrhea, vomiting, Diarrhea  started  06/17/21 and was severe for 3 weeks. Still have diarrhea  2-3  days a week. Sometimes 10 times a day. I have lost 25 pounds.
Mom reports noting swelling and erythema around 9:30 pm on 1/31. reports fever only mild tenderness. Skin warm to touch, swelling at 21 con left upper arm compared to 17 cm right arm, from upper 1/3 arm to lower 1/4 left arm reported.
constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.
Pt presented to the hospital with complaints of worsening swelling, erythema and pain to her right breast - currently breastfeeding - 3 months postpartum. Pt's son tested positive 1.5 weeks before admission - pt was tested on 1/20/22 and found to be positive for COVID 19. Patient remained asymptomatic during hospitalization. Discharged 1/24/22. Pfizer 9/24/21 & 10/15/21.
Redness at injection site, itching, burning, swelling, general pain in arm, joint stiffness. I didn?t deem it bad enough to seek treatment but enough to report it since I got this link in a text message.
Mother noticed redness and swelling at injection site this morning started treatment today with Cephalexin 250 mg/ 5ml PO suspension 1 tsp. TID x 10 days.
Initial erythematous, pruritic rash over injection site lasting days 1-3 after injection. Rash recurred day 8 after injection in same distribution - this time papular and pruritic.
Pt stood up after vaccine injection and passed out, falling over chair and hitting head on pavement. Pt responsive, awake and alert when lying on floor. Team Alert initiated. BP 102/36 hr 58 O2 sat 98%.Gauze applied to laceration above left eye. ER staff responded, pt transported to ER via wheelchair,  accompanied by mother. BP 118/45 HR 82 O2 sat 98%.
FEEL BAD; RASH ALL OVER BODY; ALLERGY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced rash all over body. On 20-MAY-2021, the subject experienced allergy. On 21-MAY-2021, the subject experienced feel bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash all over body, and feel bad, and the outcome of allergy was not reported. This report was non-serious.
Patient received Pfizer COVID vaccine at a facility on 2/2/21 and 2/23/21 (per facility representative).  Patient is an adult living facility resident. Patient admitted to our hospital (med/surg unit) on 1/10/22 with hyperkalemia for missing dialysis and was found to be COVID positive upon screening. Patient underwent a couple of dialysis runs during hospitalization and was discharged on1/12/22. During hospitalization, patient did not have any hypoxia and otherwise asymptomatic (besides his chronic cough for "months").
Patient felt light headed and had brief episode on syncope in observation area post vaccination- did not require intervention
Complete exhaustion- hardly able to move or concentrate  at 3:00 PM 0n 11/2. Pain at point of vaccination on left arm-Got worse overnight Inability to sleep (Evening and Night of 11/2) Had scary visions (Night of 11/2). Monster faces coming toward me and then vanishing. First 3 adverse events (above) continued till 4PM on 11/3-Took a nap for 2 hours, then improvement.
Became pale upon standing. Dizzy/swaying; leaning against wall. Assisted to chair. Warm and sweaty. Slow to respond. Stated vision was blurry. Pulse oxygen level 40 but after a minute or less remained in 90's. Stated he was tired. Heart rate 99 and BP: 110/70. Turned on fan. Applied ice pack. Gave water and candy. Stated stomach hurt.   Stated watching his brother get the vaccine first bothered him. Waited in the waiting room for awhile before shot and had not eaten lunch.  Monitored for 45-60 minutes. BP: 112/72; heart rate 62-72. Left with mom. The mom stated she had snacks and water in the car. Instructed to report to a doctor.
pt was seen on 30JUN05 w/temp of 40C R w/sz w/jerking of whole body, eyes rolling back in head & defecation;mom told was febrile sz;
All over body rash day 9 after first Moderna vaccine.  Presents on stomach, inner thighs , lower back, a little on the chest and some on the shoulder area leading into the nape of the neck. Red and itchy.
Patient reported loss of mobility, soreness and pain radiating from injection site distally to fingers.  These effects were estimated by patient to have begun about 4 hours after receiving shot. Patient observed to be unable to lift arm above shoulder level. She reported that this effect was worse prior to today's reporting. Patient demonstrated ability to lift left arm (no injections in left arm) above head.
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # reported as 0567AE. Exp date 14-APR-2013, dose/frequency and route were unspecified) on 27-AUG-2012 in the afternoon. Pharmacist reported that the patient called the pharmacy this morning, 29-AUG-2012, to report that she noticed that she had developed an "injection site reaction", including "mild pain and the surrounding area was raised slightly warm to the touch". The patient had not contacted the physician who prescribed ZOSTAVAX. VZVIP packet not offered because the pharmacist stated that she didn't think the patient was experiencing a rash. The patient had sought medical attention via consulting pharmacist. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information is not expected.
I am sick and my whole mouth is swollen; I am sick and my whole mouth is swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number, UPC number and Expiry Date are unknown), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced i am sick and my whole mouth is swollen. The clinical course was reported as follows: The patient got the Covid vaccine shot on 19th (not clarified) and it has been five days, he was sick and his whole mouth was swollen. Reporter seriousness for I am sick and my whole mouth is swollen was unspecified. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vaccine was administered at the patient's residence in an assisted living facility. The morning following the vaccination staff report that she was very agitated and stated she did not feel well. They called an ambulance and she was transported to a local ER, staff report that it was not at the hospital that the patient is usually seen by when when she has issues and they were concerned that the facility did not have her medical history to treat her properly. The patient's grandson reported back to the assisted living director that the patient was diagnosed with asymptomatic pneumonia, was transferred to the ICU and passed away in the night.
pt recvd vax 5PM & noticed dark, red, large swelling @ vax site; 6PM APAP given crying: high pitched, cont for approx 5 hrs; t101.5; whimpering & crying most of noc; In AM woke up very sleepy, leg still bruised & hard lump @ site;
Mom noticed a rash starting on 10/26/15 about 6:30 PM on his trunk.  No fever or any other symptoms.  Does not appear itchy.  Seen at the health department on 10/27/15 0900.  Maculopapular red rash to trunk, head, and spreading down arms and legs.  No additional symptoms.  Was seen at Medical Clinic by P.A. impression that it was a measles/rubella rash due to recent vaccination.
Initial report was received 13 October 2008 from a consumer, who is also the patient.  A 37-year-old female patient with a medical history of irritable bowel syndrome, arthritis, and frequent urinary tract infections, had received an intramuscular left deltoid injection of FLUZONE, lot number U2741AA on 09 October 2008 and five hours post vaccination, the patient developed a fever, chills, aches, weakness, and her left arm was hurting and sore to touch.  The following day, 15 hours post vaccination, the patient complained of weakness, dizziness and "passed out cold".  The patient was evaluated by her physician (date not reported) and laboratory and diagnostic tests were performed (dates of testing not reported).  The patient had normal CBC, BMP, and EKG results, and an echocardiogram had been scheduled, but had not yet been performed.  Information pertaining to the patient's recovery status for fever, chills, aches, dizziness, passing out, and left arm hurting and sore was not provided, however the symptom of weakness continued.  At the time of the report, the patient had not recovered from the event.  Documents held by sender: None.
Extreme intense onset of pain directly behind left eye.  Intensity of severe migraine or worse.  Tylenol did not relieve much pain. Facial swelling over next several hours beginning below left eye and progressing to entire left side of face, lasting several days.  Second day right side of face also swelled and after left side swelling decreased after 3 days, right side swelling increased.   Left eye became severely inflamed.  extremely red.  resembled an extreme case of pinkeye.  after two days began subsiding.
his wrist started hurting; This is a spontaneous report from a contactable consumer (patient). An elderly male patient of unspecified age (he is turning 93) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient called earlier this morning about the Covid-19 vaccine and reported that he got inoculated on Friday 15Jan2021 and everything went fine. He said that all of a sudden today, his wrist started hurting. He said that he thought it was from the vaccine, but kept doing things around the house and said that it was cracked or dislocated or something, and has nothing to do with the vaccine itself. He said that he is going to see someone about it. He wanted to let Pfizer know this. When asked for his email the patient said that he is turning 93 and has forgotten a lot more than he can remember and began laughing. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported event his wrist started hurting is likely an intercurrent condition  considering the patient's age ( elderly) and not related to  BNT162B2 .
it was pain like on her stomach, like cramps all on her stomach.; feeling lightheaded; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration, administered in arm right on 22Jul2021 10:38 (at the age of 17 years old) as dose 1, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was none. There were no additional vaccines administered on same date of the Pfizer suspect. There were no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had not adverse event prior vaccinations. There were no any relevant tests. She did not receive other products. The patient medical history and concomitant medications were none. The patient stated that she started feeling last night, when she was sleeping, she started feeling stomach pain and the whole day yesterday she was feeling lightheaded and it was pain like on her stomach, like cramps all on her stomach on 22Jul2021. Her stomach pain was like she could not move, it hurt her body to move. She stated that since she slept, lightheaded was improved on the time of reporting. She started feeling lightheaded around 17:00 she would say then when she was going to sleep around 22:00, that was when the stomach pain started happening. She was not visited emergency room and physician office. The outcome of event feeling lightheaded was recovering and pain like on her stomach, like cramps was not recovered.  No follow-up attempts were needed, No further information was expected. Information about lot/batch number could not be obtained.
Large red welt about 2 inches from injection site on upper right arm. Warm to the touch. Injection area warm after shot. Localized back muscle pain in upper right back. Her trigger point area for her normal back pain.
At 4:40 pt. received FLULAVAL IM (L) delt one minute later pt. felt that her throat swelling and closing up. Pt. was asked if she could breathe she yes but her throat was itchy and felt funny. Pt. was assessed by dr.
Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown.            Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
shingles; This is a spontaneous report from a contactable Nurse (patient).   A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left on 28Jan2021 15:00 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 30Jan2021, she began to see shingles starting under her breast, and it went into full blown shingles. She first noticed shingles barely under one breast, she noticed a little bit of a rash start and then it got worse and went all the way to her spine. It is kind of scabbing over now and she still has the deep pain. She did not have a problem with the itch, but she did have deep pain. She was not sure if it was coincidental. She was wondering if she should take the next shot. hcp gave her a medication, Valtrex, that he did not think would work since she was seen a week or two later after seeing the shingles and it should be taken when the shingles first starts. She took all of it. Patient does not think it was life threatening. she mentioned she had a problem with shakiness. Height was about 5'2", she shrunk. No prior vaccinations within 4 weeks and no AE prior vaccinations. The outcome of the event was recovering.      Information on lot/ batch number has been requested.
The spontaneous report as received from a physician refers to a 74 year old male patient. The patient's medical history included atrial fibrillation, kidney stones, hypothyroidism and benign prostatic hyperplasia. In 2012 (the physician reported may have received sometime last year) the patient was vaccinated with ZOSTAVAX). Lot number, dose, route and frequency were not reported. Concomitant therapies included NORPACE, SYNTHROID and FLOMAX. On 08-FEB-2013 the patient's varicella titer was 1.25 "lgGT" for varicella antibody. The outcome of patient's varicella titers were 1.25 "lgGt" for varicella antibody  was unknown. Reporter causality assessment was not reported. Additional information has been requested.
pt recvd vax & 30 mins p/vax exp nausea & a funny taste in mouth;
no adverse event; expired dose of VAQTA; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-APR-2019 the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R010368 and expiration date 25-MAR-2019) (dose, units and frequency unknown), intramuscularly (expired product administered). The patient experienced no adverse events. No PQC (product quality complaint) was reported.
Pt developed hoarseness and intermittent wheezing with chest tightness as well as dyspnea with exertion that is relieved by rest. Also has low grade temp, 99.6.
Received shot at 2:45 pm on 3/12/21. Starting feeling body aches and headache at 10pm. From 10pm to now 7am on 3/13/21, she has been up all night with headaches(just gave her a Tylenol)body aches,....slept minimal all night.  Her temperature is at 102.9.
This spontaneous report was received from a medical assistant (on behalf of a physician) via other company notification from Pfizer (manufacturer report number 2016558822), and refers to unspecified patients of unknown demographics. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On an unknown dates, the patients received an improperly stored (reported as "affected") doses of ROTATEQ expiration dates were not reported). The reporter stated that their daily use refrigerator was affected on an unknown date, so only 10 doses of ROTATEQ were placed in the fridge. Therefore, 10 doses of ROTATEQ were affected by temperature excursion. The reporter provided that the excursion reached the highest temperature of 49 degrees Fahrenheit for almost 2 hours on 22-NOV-2016 and 28-NOV-2016. Additional information has been requested.