chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to have a sudden heart attack on 05/04/2021. Patient was hospitalized, released to rehab and released from rehab on 05/24/2021. Patient thinks that the heart attack is related to his covid vaccine 2 weeks prior. Patient denies having any health conditions previously leading up to the heart attack.
Urticaria-type rash on trunk, neck and cheeks. No wheezes or angioedema. Benadryl was given.
soreness and pain is more wide spread to the shoulder; a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little sore) and VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little sore). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder). At the time of the report, VACCINATION SITE PAIN (a little sore) and VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder) was resolving. Not Provided      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.   No concomitant medications were provided Treated the events with Cool packs.
got the shingles shot and breaking out bumps ever since / suspected vaccination failure; breaking out bumps ever since; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for herself or himself. The age at vaccination was not reported. The patient got the shingles shot and have had breaking out bumps ever since. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Rec'd pneumonia vaccine to RD (pt had L breast surgery earlier in yr); pt developed large, reddened upper arm.
Beginning with sore throat, then shortness of breath, hoarseness, fatigue, dizziness, mouth/ jaw pain/ tooth pain, earache, fever, congestion. First symptom was swelling of the membrane surrounding the eye and bloodshot eyes. Don't have health insurance to see physician.
This spontaneous report as received from a nurse refers to a 15 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sudden sensorineural hearing loss Right ear, Prednisone 60 mg, improvement.  Sudden significant hearing loss in right ear, Seen by ENT, no cerumen impaction, given 60mg Prednisone po,, phone audiogram after dosing showed decreased hearing in right ear, repeat phone audiogram 7 hours after dosing showed improvement and clinical symptoms resolved. Bloodwork, formal audiogram, and MRI ordered.
Pt came in complaining of new onset chest pain,  SOB and pain radiating  down his left arm and his left neck. Occured all day waxing and waning with no previous similar episodes. The pain was associated with mild diaphoresis.  By the next am it was slightly improved.  Similar episodes began to occur spontaneously through out the next few days resulting in an ED visit where an EKG was found to be normal.  He was reassured and sent home and then presented to my office with continued complaints.
Flu like systems, body aches, Fever, woke her out of sleep, sore lymph nodes still swollen, fever, terrible headache. Had to take off work 01/27/21 couldn't get out of bed.
pt recv vax;exp sx similar to fatigue, fuzzy HA;flu like sx & n;
Experienced headache within 30 minutes of vaccination. Within 3 hours, started experiencing sharp pain and cramping in muscles and in joints, especially in the neck. Then experienced burning sensations and tingling in limbs.
COVID-19 Treatment; COVID-19 Treatment; 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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 at 12:00 as dose 2, single (Lot number: ER8727), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries and birch" (unspecified if ongoing); "Known allergies: Strawberries and birch" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid.
Chills, Dizzinesss and Weakness 5-10 minutes after invection.  Cough and sore throat 12 hours after injection.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 03-Mar-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 03-Mar-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 03-Mar-2022 at 11:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022 at 11:24 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 03-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 03-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
fever; general body aches; This is a spontaneous report from a contactable consumer reported for an unspecified age of adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included bnt162b2 on 27Jan2021 (product=COVID 19, brand=Pfizer, lot unknown=False, administration date=27Jan2021, dose number=1). Other vaccine in four weeks and Other medications in two weeks was unknown. The patient took vaccine at workplace clinic. On 11Feb2021, the patient left work complaining of fever and general body aches. The patient did not take any treatment for the events. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
It was reported in a published article title as stated above that a female patient with Crohn's disease, diagnosed at age of 31, on an unknown date was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unspecified). The patient was treated with Prednisone and Mesalamine. 12 years later (at 43 year old) immune studies revealed low IgG and IgM with absent antibody response to pneumococcal vaccine. On Intravenous immunoglobulin (IVIG) the severity of her inflammatory bowel disease (IBD) symptoms decreased. The patient failed treatment with steroids but responded to IVIG. The article concluded that intestinal symptoms suggestive of IBD were common in Common variable immunodeficiency (CIVD), but did not respond well to classical IBD regimen. Additional information is not expected.
About 12 hours after receiving the vaccine, woke up to use the restroom and while standing in the bathroom, I became dizzy, lightheaded, weak, and fell to the floor.  My spouse was able to arouse me after a few attempts at shouting my name but informed me that I had lost all the color in my face, lips and face were very pale.  I laid on the floor for approximately 30 minutes until I was able to sit up & stand without feeling lightheaded and dizzy.
The client suddenly lost consciousness and remained unresponsive for approx. 2 minutes, no seizure activiety noted by wife,  breathing was labored, once alert, he was weak for several hours. He was traveling at the time and was taken to local hospital.
Swelling at throat; Swelling...tongue; Swelling...lips; Could not swallow well , now is better but is still having difficulties for talk and swallow; Could not talk well , now is better but is still having difficulties for talk and swallow; Reports headache; This spontaneous case was reported by an other caregiver and describes the occurrence of OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow) and SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling..tongue), LIP SWELLING (Swelling..lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
Vomiting, febrile, crying when being touched; lethargic; (R) pupil larger than (L); photosensitivity; staggering "gait off", rash.
8/30 - hives develop on legs, back and arms; 8/31 - hives spread to face and neck; 9/1 - hives continue..worsen low fever 100.5; 9/2 - hives all over body. Hot to touch, raised; 9/3- severe hives with facial swelling baby taken to emergency room. Steroid given at ER and EpiPen prescribed. 9/4- hives continue swelling reduces; 9/5-  still battling hives even after a constant doses of Benadryl and steroid admitted at emergency room.
Information has been received from a nurse practitioner concerning a 16 week old female with no medical history who on 17-MAR-2008 and 07-MAY-2008 was vaccinated PO with 2.0 ml of the first and second doses of ROTATEQ (first dose lot # 659852/1665U and second dose lot # 659774/0140X).  Concomitant vaccine therapy included on 17-MAR-2008 a dose of HEP B (lot #654436/1106F), IPOL, ACTHIB and PREVNAR.  No concomitant drug therapy reported.  On 19-APR-2008 the patient developed severe acute diarrhea and was hospitalized (19-APR-2008 - 25-APR-2008) for the treatment of urosepsis, septic shock.  The patient required intubation for correction of the septic shock.  The patient was diagnosed as having hydronephrosis by a renal ultrasound on approximately 19-APR-2008.  The patient recovered (date unspecified) after receiving unspecified treatment.  The NP felt that the diarrhea may have caused the urinary symptoms.  On 15-JUN-2008 the patient experienced intussusception and was hospitalized.  The patient recovered and was discharged on 17-JUN-2008.  On 30-JUN-2008 the patient experienced intussusception, the barium enema was negative for intussusception but the ultrasound was positive and the patient was hospitalized until 02-JUL-2008.  The NP reported that the third dose of ROTATEQ was held.  The patient fully recovered on an unspecified date.  The reporter considered the severe diarrhea, urosepsis, septic shock, hydronephrosis and both episodes of intussusception an other important medical event and immediately life-threatening.  Additional information has been requested. 8/13/08-records received for DOS 6/30-7/2/08-DC DX: Vomiting. Intussusception. Presented with coughing, vomiting and nonbloody diarrhea. Positive upper respiratory infections. Previously seen on 6/15/08 for self reduced intussusception times 2 and was negative on barium enema and E. coli pyelonephritis on 4/08.
fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced fever and chills The patient commented that, he/she thought that the symptoms were ok than what they read. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR260656, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260656:Same reporter, same product, same patient, case for different dose
Tinnitus got noticeably worse; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain injury (Brain injury from combat.) and Tinnitus.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills). At the time of the report, TINNITUS (Tinnitus got noticeably worse) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Heart rate: increased (High) A racing heart rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-068294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains significant information: The outcome of the events changed from unknown to not resolved.
Pt received Moderna vaccine on 7/6/22 and got Pfizer vaccine on 7/30/33.
evening p/inject, rt arm swelled from shoulder to elbow (2x size) & was reddened, t100 x 2 days; rx APAP; cool compresses, elevation of arm-rest;
Hand aches and muscular pain,  Burning nerve sensations in back of neck, back aches at top of back. LEFT ear throbbing pain.
Chills. Fever. Nausea. Arm swelling and itchy. Headache.
Patient called pharmacy Tuesday late afternoon 10/01/2019 and asked if she could use advil after a flu shot. The pharmacist said yes. Patient visited pharmacy today 10/03/2019 stating her arm hurt all day 10/02/2019 and a little this morning. She wanted to report the experience. I told her that I would make a report for her.
Client stated that 15 minutes after leaving office experienced itching in ears & eyes. Went to hospital & fainted in the ER, and received BENADRYL, Epinephrine, SOLU-MEDROL & ZANTAC and was observed 5 hrs then released referred to allergist.
I feel sick; headache; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
(L) upper arm pain and swelling and redness; (L) upper arm pain and swelling and redness; (L) upper arm pain and swelling and redness; Information has been received from Food and Drug Administration (FDA) (Agency number 804223) under the Freedom of Information Act referring to a 11 years old male patient. Information about medical conditions, allergies and concomitant therapies was not provided (did not have the medical records at the reporting time).      On 26-FEB-2019 at 08:26, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# R019469 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-APR-2021; strength, dose, frequency and route were not reported) in the right arm for prophylaxis. On the same time, he was also vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot # reported as U6153AA; strength, dose, frequency, route and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (lot # reported as 33T42; strength, dose, frequency, route and expiration date were not reported) both in left arm for prophylaxis.     On 01-MAR-2019, the patient experienced left (L) upper arm pain and swelling and redness. There's no relevant diagnostic tests or laboratory data. The outcome of all events was reported as recovered (date unknown in 2019).   The causality between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information has been received from a physician on 30-OCT-2019. The reporter could not identify the patient with no date of birth (DOB).
I had a shingles vaccination and have developed a terrible rash all over my body in Dec 12 and it is still active as of March 15, 2013. It is terrible - itching and continues to break out all over my body - will it ever cease?
little soreness at the injection site; little swelling like a little knot that went little down; A spontaneous report  was received from a  consumer    female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events rash . Patient stated that she got Moderna Covid-19 vaccine yesterday. She got little soreness and little swelling like a little knot that went little down. She took Tylenol after getting the vaccine this morning. She experienced symptoms events  soreness at the vaccine site. The patient's medical history and concominant medication was not provided,. Action taken with mRNA-1273 in response to the events was not reported.
pt recv vax 28JAN98 & devel a small reddened lump on lt deltoid area & arm was sore;29JAN98 the day p/vax pt devel raised rash on both arms, face & chest;there was very little itching;dx secondary bacterial infect;had blisters;
R arm swelling with induration, erythema, warmth, tenderness and vesicles
first Moderna injection in May/2021 and did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 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. In May 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 08-Sep-2021 contains significant information, added dose two details.