chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flare up her autoimmune condition; bleeding from the nose; increase heartrate; increase blood pressure; sweating; bleeding from the eye; joint problem; fever; body aches; nausea; chills; A spontaneous report was received from a consumer  concerning herself,a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, body aches, nausea, increased heartrate, increased blood pressure, sweating, flare up of her auto immune condition, bleeding from the eye and nose, and joint problem.  The patient's medical history, was not provided.No Concomitant medications were  reported .  On 15 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A)  for prophylaxis of COVID-19 infection.   On an unknown date , the patient experienced Fever,chills,nausea,pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up of her auto immune condition(Auto immune disorder NOS), eye haemorrhage,epistaxis, and joint problem . No seriousness reported for events. Seriousness of event autoimmune disorder considered to be to medically significant according to IME list.  Treatment for the events  was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Fever,chills,nausea, pain, increase heartrate, increase blood pressure, hyperhidrosis, flare up her auto immune condition(Auto immune disorder NOS), eye haemorrhage, epistaxis, and joint problem was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
constant burning on chest; Patient has sore throat; little bumps on back of my throat; uncomfortable gastric; both arm got sore; Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], VITAMIN A [RETINOL] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine). On 05-Sep-2021, the patient experienced PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric) and MYALGIA (both arm got sore). On an unknown date, the patient experienced CHEST PAIN (constant burning on chest) and OROPHARYNGEAL PAIN (Patient has sore throat). On 01-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) had resolved. At the time of the report, PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and MYALGIA (both arm got sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Heart rate: high (High) fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has reported that she also had Jansen COVID-19 vaccine given to her on 1-June-2021. No treatment information was reported.
Patient presented to the ED and was subsequently hospitalized on 5/10/2021. Diagnosis was Intraparenchymal hemorrhage of right temporal lobe of brain, nontraumatic. He was also admitted on 5/19/21 for angiogram. These visits are within 6 weeks of receiving COVID vaccination.
Night after the shots he got rashes on his arms and chest. The next day he woke up with a fever that got up to 104+ and he was tired, complained about his leg hurting, and had a distinct loss of appetite/ water had to be forced.
Patient noticed left arm swelling & pain day following immunization. 2 days after immunization, swelling began in right arm. Patient seen by ER on day 3, with bilateral upper extremity pain & swelling. Admitted to hospital to treat for presumptive rhabdomyolysis and to monitor for compartment syndrome.
Patient experienced a syncopal episode, assisted to ground, nauseated, vomited, IV started, transported to hospital via ambulance
?Covid Arm?. Swelling/hives and pain in upper arm around the injection site. Started 10 days after the vaccination was given. The swelling doesn?t appear anywhere else except for on the upper half of my left arm where the vaccine was administered.
Hallucinations, Headache, Myalgia, Arthralgia, headache, persistant-parietotemporal and nothing relieves it Narrative: went to Clinic- advised to use nsaids. has been using alpha stim for musclle aches and headache but nothing relieves the headacke-asking for neurology appointment from her pcp
1 week after injection, a large red itchy rash appeared - 3 days later, the rash still appears - used anti-itch cream on rash and it helped a little but rash hasn't subsided.
itching was gone again after Moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Itching (all over my body that I had for years).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) had resolved.            No concomitant medications were provided by the reporter.  Treatment information was not provided. My itching all over my body that I had for years disappeared after my first Moderna shot February 1, 2021 the next day. About two weeks ago some of the itching recurred, so I got a Moderna booster shot and my itching was gone again.   This case was linked to MOD-2021-278963 (Patient Link).
About 30 minutes after injection Pt started having itching inher feet and it spread over her whole body. Hot first then feet tingling. Came back to observation site and staff administered a benadryl injection at 12:40ish. At 1:14 still very itchy.
PATIENT RECEIVED MENINGITIS B OUTSIDE OF RECOMMENDED AGE. PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS OF REACTION AFTER DOSE WAS GIVEN DURING TIME WAITED IN CLINIC.
Varicella-like rash at injection, erythema extending to entire exterior surface of left arm, onset approx 36 hours after injection
Extreme difficulty breathing upon exertion, collapsed shortly after walking started, loss of conciousness,  and death
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 29th March 2022, the patient received Engerix B pediatric. On 29th March 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received an expired dose of Engerix B pediatric. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix B pediatric which was already expired, which led to expired vaccine used.
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
BlurredVision, Dizziness, Headache, Myalgia, "swollen glands"; fatigue; injection site discomfort; "stomach ache" Narrative:
Severe dizziness within 1/2 hour of vaccination. Stomach queasiness the next day. Vomiting the day after that. Slow recovery with weeks of dizziness/queasiness now sporadic and slight.
Palpitations, heart fluttering, diagnosis of idiopathic ventricular tachycardia
Urticaria and severe dermatographism that started 9/29/22 requiring high dose antihistamines and a leukotriene receptor antagonist to get under control.
The injection site became very red and swollen and hard for at least 4 days, then it became tender and itchy, and it continues to be red, and slightly inflamed and itchy.
No additional AEs reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection, at a dose of 0.5 milliliter, lot #U026796, expiration date: 28-JAN-2023, administered intramuscularly for prophylaxis (anatomical location was not provided) (expired product administered).  No additional adverse event was reported.
RASH AT GROIN AREA (INITIALLY IN MINOR AMOUNT, OINTMENT MADE IT WORSE); This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient experienced rash at groin area (initially in minor amount, ointment made it worse). On 21-SEP-2021, treatment medications included: hydrocortisone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rash at groin area (initially in minor amount, ointment made it worse). This report was non-serious.
Pt had Pediarix at 2mo, no SZ symptoms, and mother stated that after DTaP at 4mo visit, and pt developed head body twisting movement, within 20 minutes, pt's eye was opened, but not responeded to parents, no vomiting, no another episodes since then pt gaining weight well.
SHINGLES--Rash on left side of back erupted on  4/6/21.  Saw dermatologist on 4/7/21 and began taking VALACYCLOVIR on 4/7/21
Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; This is a spontaneous report from a contactable nurse (patient herself).  This 51-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 28Dec2020 at 16:00 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included type 2 diabetes. No known allergies. Relevant concomitant medications included metformin, pravastatin and paracetamol (TYLENOL). The patient was vaccinated at hospital, age at vaccination was 51-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed On 28Dec2020 at 17:00, the patient had mild headache within first hour relieved some with paracetamol (TYLENOL). 12 hours after injection, awoke to severe headache, and nausea. Unrelieved with TYLENOL after one hour. She took ibuprofen, 'CLARITIN' and ondansetron hydrochloride (ZOFRAN).  Eventually relieved 1.5 hr after that. The patient recovered from both events in Dec2020.
Chicken pox outbreak in school. Developed chicken pox rash 02/08/2002 (mild).
No additional AEs; HCP called for evaluation of vaccine temperature excursion; This spontaneous report was received from a medical assistant referring to a 31-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 05-AUG-2022, non-supported frozen vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/once, lot #W005208, expiration date reported as 14-FEB-2023 but upon internal validation established as 14-FEB-2024 (strength, and route of administration were not provided) was administered for prophylaxis during temperature excursion (Product storage error). No further information provided. No additional adverse events (AEs).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008022:
i suspect that the booster shot adversely affected my back. although i had been weight lifting nothing had changed and the pain went away by itself.  so at some point within a week or two of booster shot i started feeling this weird, never before felt, achy lower back pain at almost my hips. it felt very central in my midsection with a 3 out of 10 pain. after a couple times of working out thinking it would go away its like it got aggravated and i got sore like a 7 out of 10 pain. if i sat down for a while, i looked like an old man getting up as i was hunched over for 10 seconds while i walked around. i did not have any reaction like this to the first 2 pfizer vaccine shots. again, i only suspect, but i highly suspect this. after about a month and a half to two months my back started slowly feeling better. i am now 100%. it was a stiffness and weird pain i had never felt before. it was center lower back almost more like it was inside the top of my hips (center of torso) and not like a back spine pain. it was just achy and like i would feel it at weird times like sitting down and getting up. if i walked around i would be just fine. if i was trying to lay in bed or put on or take off socks it was painful with varying degrees.   i had seen a chiropractor and a physical therapist who did not pinpoint an injury caused by working out. they did not pinpoint a pain cause.
The time that was between the 1st vaccine & 2nd shot was basically when RA symptoms began. Started with a pain in my jaw and pain in shoulder. Pain in jaw lasted a week, then added pain in my shoulder and hands throughout the weeks. I was referred to an RA doctor and did a number of blood tests, and was diagnosed with Rheumatoid Arthritis. I was prescribed Leflunomide & Hydroxychloroquine and since then the pain has subsided.
Developed bilateral hand swelling which persisted till mid December. Went to his primary care provider on 11-12-18 for hand swelling and 12-17-18. He was tested for RA, on 12-20 he was hospitalized c pantocytopenia, hyponaturia and rash which was dx on 12-25 as lupus.
WVU Nursing Student administering vaccine to R delt. Syringe leaked around needle during injection and less than half of vaccine was administered. Full dose administered to L delt per CDC recommendation. Pt monitored for 15 minutes after vaccination.
patient developed 2 large lymph nodes on the left side under her arm. one the size of an orange and the other the size of a golf ball
Patient reports a history of syncope with any sort of injection or vaccine. Five minutes after receiving her vaccine, she felt lightheaded and lost consciousness for a few seconds. Prior to losing consciousness she asked for assistance and somebody held her up when she lost consciousness. She did not hit the ground or otherwise injure herself. Upon awakening, she was fully alert and oriented and denied any chest pain or shortness of breath. Drank Gatorade. Felt better with no recurrence after observation period.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 76 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN9581), on 17Feb2021 as dose 2, single (Lot number: EL9266) and on 28Sep2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "High Cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, latency 1 year 11 months 29 days 20 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Feb2023 to 11Feb2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID 19) and BNT162B2.
Fever up to 101.4 for 24 hours, body aches/muscle fatigue, sore throat and loss of voice, headache, chills. 30 hours later still no voice but other symptoms have resolved. Took Tylenol to bring down fever
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE BEACH  ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
This spontaneous report as received from a pharmacist who is also the patient of unknown age reporting on herself. On 23-FEB-2016 the patient was preparing ZOSTAVAX vial (lot # L032184; expiry unspecified) (dosing regimen unspecified). No concomitant medications were reported. The pharmacist called to report that after reconstitution the ZOSTAVAX today on 23-FEB-2016 the vial leaked out of the rubber stopper while withdrawing the ZOSTAVAX solution up into the syringe. Product quality complaint filed. The pharmacist indicated that some of the ZOSTAVAX solution dripped onto her hand. Pharmacist declined to participate further in the AE report stating there were no adverse effects as result of the ZOSTAVAX dripping onto her hands. No further AE information was provided. Additional information has been requested.
Information has been received from a physician concerning an over 11 year old female who was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced dizziness. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested.
Fever, chills. Redness, swelling at injection site, also felt hot to touch. She saw a provider at her PCP office 10/18/18, they drew around the area. She has been treating with BENADRYL and ice, and the site has decreased in size over past 24 hours as of 10/19/19.
On May 11, 2022, the patient listed above came in for childhood vaccines.  Child was given Hepatitis A 1st dose, Hepatitis B 2nd dose, HPV9 - 1st dose, MMR - 1st dose, TDAP - 2nd dose, and IPV - 1st dose.  After patient was given her sixth vaccine, which was the IPV nurse was applying Band-Aids to the patient when patient experienced a syncopal episode.  Patient easily aroused within a few seconds.  Patient was immediately placed in supine position.  Vitals obtained at 09:38 a.m. which where 119/63 HR 64.  Patient complained of dizziness and scratchy throat.  No difficulty breathing.  Remained in clinic for 15 minutes and walked to waiting area on her own accord.  Patient was reassessed at 10:00 a.m. in the waiting room and was still complaining of scratchy throat and some dizziness.  Patient returned to the clinic area and placed in supine position and vitals reassessed at 10:05 a.m., which were 118/80 HR 65.  Patient continued to complain of scratchy tightening throat but no SOB.  Decision was made to call EMS for further evaluation at 10:12 a.m.  EMS arrived and evaluated patient and recommended transport to the ED for further evaluation and mother declined.  Patient left clinic on her own accord accompanied by mother.
Patient became light headed and pale approximately 5 minutes after injection. Did not pass out. Patient sitting and given water. 10 minutes later patient feeling better and left 30 minutes after injection.
she had a 24 hour urine test (performed 5 days ago) that "showed a lot of stuff in my urine and that I have an adrenal gland problem and now I need to have an MRI; had a 24 hour urine test that "showed a lot of stuff in my urine"; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her first vaccine dose on 16Mar2021 and afterwards (Facility name) scheduled her second dose for 28 days later. She reports that her understanding it that the doses should be 21 days apart and asks if this changes the effectiveness. Before she got her first vaccine dose she had a blood test showing that her "Plasma acth" went up. After having the covid vaccine she had a 24 hour urine test (performed 5 days ago) that "showed a lot of stuff in my urine and that I have an adrenal gland problem and now I need to have an MRI". She was asking if its ok to have the second dose if she has an adrenal gland disorder? She had difficulty explaining the tests and condition she was currently being worked up for.  No follow-up attempts possible. No further information expected.