chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Red, hot spot on arm around injection site; This is a spontaneous report from a non-contactable consumer(patient). A 54-Year-Old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6202) via an unspecified route of administration on right arm 03Mar2021 at 12:30 (at the age of 54-years-old) at SINGLE DOSE for Covid-19 immunisation at Hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient not been tested with Covid-19. It was reported that the patient was allergic to penicillin. The concomitant medications in two weeks included METFORMIN HYDROCHLORIDE, SITAGLIPTIN (Janumet), NEBIVOLOL HYDROCHLORIDE (Bystolic), LOSARTAN POTASSIUM (Losartan), Glimepiride. The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration on right arm on 10Feb2021 at 16:15 as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 03Mar2021 at 19:00 the patient experienced 100+ for 60 hours; 102°+ for 48 hours, Red hot spot on arm around injection site - 72hours. It was reported that no treatment was given. The patient underwent lab tests and procedures that included body fever of 102+F and 100+F on 03MAR2021. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
On 2/16/2021 in the morning I found that I was fatigue for about 4 - 5 days and at 85 it knocked me ion a ditch., with fatigue and a bad back it exploded a bit.  I felt a little winded and did deep breathing exercises.  I did not see a doctor, as I expected some symptoms.   I spoke to my doctor about my back and I went to see a chiropractor and he gave me some adjustments and I felt real good after that
Six minutes in I felt flushing and heart pounding and some swelling in my throat. I had pre-medicated with benadryl so I took another one. The heart pounding eased in just a minute or two and also the flushing. I had had an allergic reaction to Moderna January 7th , so thought I was ok to just go home and take the same meds the ER had given me in January. I called my doctor's office the next day to get more prednisone.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Headaches; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received first dose of BNT162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: EN6198) via an unspecified route of administration in the right arm on 01Mar2021 at 15:30 as a single dose (at the age of 73-years-old) for COVID-19 immunisation and also received second dose of BNT162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 as a single dose for COVID-19 immunisation. The patient had known allergies to food, medicine and other products. Medical history included diabetes. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 01Mar2021 at 15:00, the patient experienced headaches and fatigue. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches and fatigue was resolving.  No follow-up attempts are needed. No further information is expected.
60 yo patient given High Dose Flu Vaccine which is indicated for 65 yo and up age group
This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A 15-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had an unexpected therapeutic response (toenail fungus started to improve after the vaccine), with outcome of unknown. Additional information: 15-year old son had the Pfizer COVID-19 vaccines. His toenail fungus started to improve. Expiry date of COVID-19 vaccine: Not provided. Other products: Not provided. Investigation assessment: Not provided. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Woke up 5 days after covid vaccination with small bumps under left ear; next morning I had about 4 bumps under right ear and 2 blebs on neck at hairline. All itched like crazy.  The blebs had a red mark in center. Applied polymixin x 3 days. Bumpas still present but are smaller and do not itch.  I really think these are bug bitees.
pt recvd vax 4AUG93 mom reports pt cried unconsolably from 6PM until 2AM 5AUG93; high pitched crying, swelling & tenderness noted @ inject site by mom;
Patient has skin irritation that was wart like soon after vaccination. Area is still painful and has grown in size since vaccination in April. Patient states she has not picked at area but skin shows trauma and excessive irritation.  Patient has never reached out to an urgent care provider or primary care provider about this issue. Vaccine area looks lower than it should have been for IM. I encouraged patient to talk with her PCP about treatment options.
While in recovery about 13 mins pt complained of dizziness, headache became clammy, diaphoretic. no LOC, no SOB no nausea or vomitting. Rt arm vaccine site benign, no redness, no swelling. Applied ice pack to neck, gave water for hydration. pt stated only coffee in am little nourishment Elevated feet. VS taken 10:30  138/80, hr rate 81 reg strong. resps 16 reg non labored 97% O2 sat. Monitored for 30 min. Pt stated "I feel much better" Provided reassurance, encouraged hydration, arm movement, tylenol for aches if needed.  Okd to exit after 30 min.
10 Days after vaccination in the left arm the patient developed a shingles like reaction that was diagnosed and treated by above physician as if the lesion were shingles.
head pain, shortness of breath, coughing, dizziness, blurred vision, numbness on left side
Fever 1 week after vaccine administration, Dx with chicken pox 10 days after vaccine administration
Pt recv vax on 11/9/98; on 11/10/98 pt exp lt arm 6 in area of erythema, warmth, edema between shoulder &elbow; left axillary node enlarged; tx=ice, elevate,Keflex
Pt was expecting to receive the BiValent Pfizer vaccine and instead was given the Monovalent Pfizer.
Unusual Fatigue (periods of 14-15 hours sleep), Low grade fever on and off,  appetite loss, almost two weeks after a raised injection site and red rashy arm
2 days after receiving the vaccine on 11/18/21 I began to have heavy vaginal bleeding and pelvic pain. today is day 13 of pelvic pain, vaginal bleeding and clots. I was seen in the Emergency Room on saturday 11/27/21 because the pain had become worse, i was feeling lightheaded and fatigued. i was unable to report to work that day and on sunday 11/28/21 due to the pain. the pain is mostly located on my left lower pelvic region but at times refers to my left lower back and throughout my pelvic and perineal region.
Patient complaining of injection site being red, hot and inflamed about a quarter in size reports no fever, taking ibuprofen to help with pain.
Chills, body aches, soreness at the injection site, and fatigue. Symptoms began approximately 12 hours after inject. Symptoms continued for approximately 12 hours. Body aches were relieved with OTC medicine. Soreness at the injection site relieved approximately 36 hours after injection.
Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of Gardasil (yeast) (lot#653938/0954F). The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of GARDASIL (lot # 653938/0954F). Follow up information reported that the vaccination was administered by the IM route. The initial report of being vaccinated SC was charted incorrectly. The patient's chart was corrected by the nurse who gave the injection. The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. No further information was available.
pt recv vax;devel red & swollen arm;employee felt there was a problem w/ the lot;
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 10:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
EVENING OF VACCINE BEGAN VOMITING AND WAS UNABLE TO KEEP DOWN FOOD. ALSO HAD BODY ACHES WHICH HAVE NOT RESOLVED AS OF 4/19/22. CURRENTLY FEELING MARGINALLY BETTER BUT UNABLE TO TOLERATE FOOD AT THIS TIME.
About the first week in January 2023 I came down with flu like symptoms I was strongly positive with COVID-19 my first time. I called my doctor and received a prescription for PAXLOVID and within twenty four hours felt completely normal. I felt normal for about five weeks and then began to have flu like symptoms I tested negative with an expired test. I felt extreme tiredness and fatigue for the next few weeks but I had no GI symptoms or chills just an overwhelming tiredness. After about two weeks of this I called my doctor I had weird symptoms of my skin feeling weird and my neck pain returned as well including my right arm and scapula. It was about five weeks before I began to feel even a little bit better and began to walk short distances again and within another week up to three miles again with elevation gain.
After receiving Gardasil at about 920am the pt stated R arm felt weird then turned pale, eyes dilated and fainted. Dr was called into the room immediately and examined pt and observed her for 45-50 min, then pt acted normal and went home.
PT states getting J/J vaccine on tuesday, states lightheadedness and nausea today with headache and fever yesterday. 20-year-old male who reported to the emergency room with symptoms consistent with resolving side effects of coronavirus vaccine and/or mild dehydration.  Patient's nausea resolved after 4 mg of Zofran and he subjectively felt better after 1 L of normal saline hydration.
Warm to hot; Itchy; Rash at injection site; Large red area at injection site, 4 by 5 inches like circle; Swollen; Little burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Large red area at injection site, 4 by 5 inches like circle) and VACCINATION SITE SWELLING (Swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little burning at the injection site). On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Large red area at injection site, 4 by 5 inches like circle) and VACCINATION SITE SWELLING (Swollen). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Large red area at injection site, 4 by 5 inches like circle) and VACCINATION SITE SWELLING (Swollen) outcome was unknown and VACCINATION SITE PAIN (Little burning at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient informed that she was going to take a pill of topical diphenhydramine that night as treatment.
Pt describes a red rash that developed to bilateral forearms about 3 days after first SHINGRIX injection. Pt attributed her sx to gardening the day prior. After second SHINGRIX vaccine pt reported another rash to bilateral forearms, this time "much worse."  Pt describes the rash as looking like pimples, and PCP (who saw photos) described the rash as vesicular. Pt denied any pain or pruritis. About 9 days following vaccination (6/7) pt recalls Dr. inquiring about her droopy eyelid. Pt did not experience any numbness or tingling at that time, but presented to the ED 7 days later (6/14) with numbness to left arm and left cheek. Diagnosis possible TIA. Pt put on statin and aspirin therapy.
t99.9 +, vomited twice, HR 200/min & liver enlargement;
Patient started to develop sores and inflammation in his mouth about a week after receiving the MMR vaccine. He self treated, he took OTC Advil and use salt water gargles to treat his symptoms. Symptoms resolved about one month later.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 at 13:00 as dose 1, single (Lot number: FR8732), in left arm, on 21Apr2021 at 14:00 as dose 2, single (Lot number: FR8731), in left arm, on 23Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 09Aug2022 at 13:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Remission for breast cancer" (unspecified if ongoing); "double mastectomy", start date: Jun2022 (unspecified if ongoing); "radiation", stop date: 19Sep2022; "chemotherapy", stop date: 23May2022; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LYRICA, start date: 01Feb2022, stop date: 17Feb2023. Past drug history included: Keytruda, stop date: 19Jan2023, for immunotherapy, notes: immunotherapy with Keytruda ended 19Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 08Feb2023, Treatment stop date: 12Feb2023, Indication: Treatment of COVID-19
5cm tender induration at site (R biceps) with redness extending entire fore arm and pain at site of injection (Gardasil).
Patient was admitted to hospital on 01/22/2022, testing positive for Covid.  Patient had an abnormal chest X-ray and had developed pneumonia.  Patient had a cough and was short of breath.  Patient has pre-existing medical conditions: type 2 diabetes, hypertension, and severe obesity. Records were recorded by hospital.  This is document is supported by those records.  Number of hospital days was not charted, no discharge date given.
I was about 6 weeks pregnant when I received the vaccine on 12/26/20. I had a miscarriage on 1/1/21.   I have a pregnancy history of one prior healthy full term pregnancy in 2019.
Treatment of COVID-19; Treatment of COVID-19; 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 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "history of coronary bypass" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, stop date: 26Sep2023; ATORVASTATIN, stop date: 26Sep2023; OMEPRAZOLE; EZETIMIBE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (14Oct2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 26Sep2023 to 01Oct2023.
sinuses; little bit of rash; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event in December 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported she had COVID-19 Virus back in December and she still has fatigue, headache, sinuses, little bit of rash, and she analyzed herself with long-term symptoms of COVID-19  No treatment information was reported.
My first dose was Johnson and Johnson seven months ago; this dose was a Moderna booster. I went in to get an MRI, because of my neurological condition and a nodule was found on my thyroid. I then had to have an ultrasound, where they found four of them. Today, I had a fine needle biopsy and am awaiting results to see if it is benign or cancerous.
Extensive limb swelling of the left upper arm, shoulder to elbow with significant pain, redness, warmth to touch
Ears began ringing with a high-pitched sine-wave type of sound or blend of noises in very early January. It has become louder and is loud at all waking moments now, currently it sounds like dental drills inside my ears but just the noise. It varies between a consistent frequency or a blend of slightly different frequencies. It sounds like sine-wave electronic-created noise. I continue to have good hearing for hearing normal things, but the ringing makes it difficult often to discern what is being heard. At night if I wake up the ringing is very loud and prevents attempts to gain sleep. I have setup to visit my PCP and will let him know I completed the VAERS for my ears because it has gotten worse daily for many weeks now.
Pt received MMRV and Hib at 15 mo visit - 10/7. 10/8-9PM went to ER with temp 103 and ? seizure activity at home per dad's hx. Tylenol given at home ineffective. Dx with Febrile Seizure. Seizure activity 40 seconds.
Muscle pain joint pain worst headache ever muscles in neck froze up diapers vomiting rash fever pain in side
The next morning starting around 11am, Feb. 5th I had 101 degree temperature, a headache, and the chills for the whole day. The following morning Feb. 6th I had a headache that continued all day and I was very tired but no other symptoms.
Headache that will not go away (I do not suffer from headaches), brain for and confusion (unable to conduct work for bookkeeping, unable to do simple math), inflammation on both hands (unable to remove wedding ring), joint pain, shortness of breath (never had that before).
Pt recv vax on 11/11/98; on 11/17/98 pt exp red, raised rash; tx=Benadryl, oatmeal baths
Severe diarrhea on Sat then vomiting the next morning, Sun.  I was in bed all day Sunday unable to do much with a headache and lethargy.  I woke a bit better on Monday but still had a headache.  Today, Tuesday I feel foggy brained and don't feel like I'm breathing at full capacity.
ELEVATED BLOOD SUGAR OF 400; STOMACH CRAMPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcohol user, and non-smoker. The patient has no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on right deltoid muscle on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  In MAR-2021, the patient had elevated blood sugar of 400. On 15-MAR-2021, the patient visited urgent care where her capillary blood glucose was 400 (units unspecified). In 2021, the patient experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach cramps, and had not recovered from elevated blood sugar of 400. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210410812-covid-19 vaccine ad26.cov2.s -elevated blood sugar of 400. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Approx 10hours post vaccination, headache, nausea, dizziness, chills, fever, body aches, joint pain lasting approx 30 hours. Followed by diarrhea lasting  an additional 48hours.