chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full body hives and angioedema started on 01/03/22. I've now been diagnosed with Chronic Spontaneous Urticaria. I've never had hives prior to this date.
Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; General malaise; tired; feverish; arm pain; not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness; Extended worsening chronic painful left shoulder, muscle, arm pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 54 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route, administered in Arm Left on 26Jan2021 at 12:00 (54-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included asthma, allergic to Sulfa drug, Sumatriptan. The patient's concomitant medications included albuterol sulfate inhaler within 2 weeks of vaccination. The patient previously took sumatriptan, sulfa drug and experienced allergy. The most recent COVID-19 vaccine facility was administered was reported as Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route of administration in Right arm on 09Jan2021 at 20:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 26Jan2021 at 12:00, the patient had experienced continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore. Chronic hip / shoulder weakness. General malaise, tired, feverish, arm pain for 2 days post vaccine. Extended worsening chronic painful left shoulder, muscle, arm pain. She was being able to run 2 plus miles and workout to not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness. It's like it set off a subtle weakness in all her joints. These adverse events resulted the patient to doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included blood work and imaging: result not reported. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
an expired dose of Pediarix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received Pediarix. On 24-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: an expired dose of Pediarix was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter consented to follow up via email. The patient received expired dose of Pediarix, which led to expired vaccine used.
Information has been received from a physician concerning a 19 year old male who was vaccinated with MMR and subsequently, the pt experienced measles that covered his body from head to toe. His rash was described as "textbook measles". The physician who relayed the information to the reporter indicated that the pt's symptom was due to vaccine failure. Follow-up information received 9/17/99 from a physician indicated that lab studies done were given at another office and he did not have the pt's records. No further information is available.
I administered a 3 and older 0.5ml dose of Flu vaccine to a patient 24 months old.
HUSBAND CALLED AND SAID PATIENT EXPERIENCE ALLERGIC REACTION. SHE HAD HIVES AND WELTS ALL OVER BOTH ARMS FOR WEEKS UNTIL HER SECOND DOSE. THE HIVES AND WELTS COME AND GOES.
irritable bowel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included LOSARTAN for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included over the counter gas medicine (unspecified).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4in circumference warm/red area near pneumovax injection site. Probably minor local reaction. 4in after 2 days - no growth after first day.
vaccination site sore; Minor rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site sore) and VACCINATION SITE RASH (Minor rash) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site sore) and VACCINATION SITE RASH (Minor rash). At the time of the report, VACCINATION SITE PAIN (vaccination site sore) and VACCINATION SITE RASH (Minor rash) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
4.16 sore arm, swollen arm.  4.17 sore arm, swollen arm, low grade fever, chills, body aches
Chills. Sweats. Headache. Extreme pain in right breast. Pain in right side rib area
diagnosed with Polymyositis; high liver enzymes; high muscle creatine levels very high; extreme weakness; muscle pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EN6204) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Brand: Pfizer, Lot number: EN6205, Dose number: 1, Vaccine location: left arm), administration date: 19May2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: POLYMYOSITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "diagnosed with Polymyositis"; HEPATIC ENZYME INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high liver enzymes"; BLOOD CREATINE INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "high muscle creatine levels very high"; ASTHENIA (non-serious) with onset Sep2021, outcome "not recovered", described as "extreme weakness"; MYALGIA (non-serious) with onset Sep2021, outcome "not recovered", described as "muscle pains". It was reported that during routine blood work 6 weeks after the 2nd dose, the patient had high liver enzymes. After further testing, they found high muscle creatine levels very high. Now, the patient was diagnosed with Polymyositis after extreme weakness and muscle pains. The patient underwent the following laboratory tests and procedures: blood creatine: (Sep2021) high, notes: very high; hepatic enzyme abnormal: (Sep2021) high; sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyositis, hepatic enzyme increased, blood creatine increased, asthenia, myalgia which includes taking steroids (unspecified, as reported).; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient fully vaccinated with Pfizer on 2/10/21 and 3/3/21. Patient admitted to the hospital for COVID pneumonia on 10/12/21. Patient in and out of the hospital several times for the same reason. Admitted 10/12/21-10/18/21, 10/20/21-10/28/21.
Varicella vaccine admin 1/4/12 RUA, sq. Pt presented at clinic 01/15/12 for "bites" on buttocks & LA, started on KEFLEX for cellulitis. Infected pox lesion (L) upper arm - onset 1-14-12, pox lesion perineum on 1-4-11
i missed an appointment for my second dose that was supposed to be on friday.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (i missed an appointment for my second dose that was supposed to be on friday.) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (i missed an appointment for my second dose that was supposed to be on friday.). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (i missed an appointment for my second dose that was supposed to be on friday.) had resolved.
Patient experienced muscle pain and stiffness in her whole body starting about 12 hours after her shot and lasting for about 24 hours.  Her muscle pain and stiffness gradually disappeared and was completely gone after 24 hours.
T - 101.2 eve on immunz.  Fussy.  TYLENOL, call if sx worse.
Encounter for monitoring bridging anticoagulation therapy - hospitalization within 6 weeks of receiving the COVID vaccine. ED visit for scalp contusion. Treated and relseased - also within 6 weeks of receiving the COVID vaccine.
Started feeling kind of weak and achy the day at about 7:30 AM on 1/19/21.  Took 2 Tylenol at 8, and that seemed to help.  Temp at that time was 99.5, then took Tylenol which did not control the fever, but did help with the achiness.  Started getting worse when Tylenol wore off, took temp at 11:00 was 100.3.  Body aches, weakness, chills.   Has taken a nap but still feeling weak and achy, still with headache.  Came home from work and laid down.
Information has been received from a health professional concerning a 17 month old female with a history of otic infection and upper respiratory infection and no known allergies who on 10/01/2000 was vaccinated with a dose of varicella vaccine. On 03/06/2001 the pt developed a varicella rash. Current therapies included MMR vaccine, hep B vaccine, amoxicillin, acetaminophen, DTaP and Prevnar. Unspecified medical attention was sought. No further info is available.
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant.  A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization.  Medical history included tachycardia, tension headache, and glucose tolerance impaired.  Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN).  On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit.  The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021.  On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed:  potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pruritic scaling erythematous patches on trunk predominantly, minimally on arms/upper legs with mild fatigue and chills
difficulty closing hands; fatigue which is still ongoing; experienced weakness; experienced nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAY-2023, the patient received the 1st dose of Shingrix. On 20-MAY-2023, 10 hrs after receiving Shingrix, the patient experienced movement disorder (Verbatim: difficulty closing hands), nausea (Verbatim: experienced nausea), fatigue (Verbatim: fatigue which is still ongoing) and weakness (Verbatim: experienced weakness). The outcome of the movement disorder was resolved and the outcome of the nausea was resolved (duration 5 days) and the outcome of the fatigue and weakness were not resolved.   It was unknown if the reporter considered the movement disorder, nausea, fatigue and weakness to be related to Shingrix.     It was unknown if the company considered the movement disorder, nausea, fatigue and weakness to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2023 The reporter reported that about 10 hours after receiving Shingrix first dose he had difficulty closing his hands. This was resolved.  The reporter also stated that for about five day he experienced nausea. This was also resolved.  The reporter also stated he experienced weakness and fatigue which was ongoing. Adverse Event was filed for all events. The reporter did not consent to follow up.
The pt received the first vaccine at 9:15 on 7/31/00. At 9:30 (same day) she complained of lightheadedness, nausea, and shortness of breath. She was taken to the ER where she was treated with Benadryl, Phenergan, IV hydration. She was discharged and sent home with oral Benadryl and Pepcid.
Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm; Heartbeat was extremely fast, irregular; Felt heart pounding in her chest; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest). At the time of the report, HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 188 rpm (abnormal) 188 rpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment medication was reported.  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.
rash on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on her arm at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE RASH (rash on her arm at the injection site). The patient was treated with HYDROCORTISONE (BACTINE [HYDROCORTISONE]) at an unspecified dose and frequency. On 30-Jan-2021, INJECTION SITE RASH (rash on her arm at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
first 72 hours after first dose - fever, chills, extreme fatigue and body aches first 48 hours after second dose - fever, chills,  extreme fatigue and body aches 72 hours after second dose -  extreme fatigue and body aches days following second dose - still extreme fatigue, feels not 100%
On 2/23/06 patient presented with mild case of chicken pox in an immunized child with pharyngitis. Throat culture done which was negative. Immunization records obtained through school.
This case was reported by a physician via sales rep and described the occurrence of seizure in a 16-year-old female patient who received BEXSERO. The patient's past medical history included seizure. On an unknown date, the patient received BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: The other healthcare professional reported that the patient experienced seizure on the same day after receiving BEXSERO. Prior to receiving BEXSERO, the patient did not have seizure for a long period of time. The sales representative had limited information, but the other healthcare professional had additional information which could be obtained by follow up.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patient were vaccinated with improperly stored doses of M-M-R II (lot # K021950, expiration date: 10-NOV-2016 and reported lot # 002036, expiration date: 10-FEB-2016) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. It was determined that Lot number 002036 is not valid for M-M-R II, however lot number K002036 is valid for M-M-R II with status albumin: rHA. Additional information has been requested.
Patient called Clinic Pharmacy  at 12/05/20 around 10AM , reported a spike in fever at 4.00PM same day vaccine received. Area of injection tender, swollen red and warm to touch. Fever lasted for one day all other symptoms continued  present up to day of call in to pharmacy (4days ) 12/ 05/2020. Patient was advised to go the ER or hospital if no improvement or symptoms worsen. 12/05/2020 patient reported symptoms improving and not worsening than previous day 12/04/2020.
DIED; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date the patient died from unknown cause of death and It was unknown if an autopsy was performed or not. It was reported as " My father died a week after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221166018- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Swollen red area, started at 1&1/2 x 1&1/2 and grew to 3x3 by Tuesday. No temperature was hard on 6-12-17, but not as hard on 6-13-17. She was using ice packs and her physician was going to order an antibiotic and possibly a low dose steroid, after researching low dose steroid use before ZOSTAVAX shot .
pt recvd vax 8 hrs later red blotchy patches appeared all @ once on upper rt thigh;