chrisvoncsefalvay/vaers-outcomes huggingface dataset:
85 Y male remote smoker with hx significant for hyperlipidemia,  COPD (no PFT on file) , chronic kidney disease (baseline creat 1.1-1.2), prior osteomyelitis of right 2nd toe s/p amputation and atrial fibrillation on anticoagulation therapy who presented to the Emergency Department with generalized weakness and fever admitted for weakness in the setting of COVID +.    Sepsis secondary to COVID Patient med sepsis criteria on presentation given fever and tachycardia with slight tachypnia. His presenting symptoms are weakness and fall. No respiratory complaints and he is saturating well on RA.  - Continue to monitor oxygen saturations - Clinically not meeting criteria for systemic steroid, or antiviral    Weakness - PT eval with recommendation for SNF.   Urinary retention - Continue foley catheter for now, voiding trial at SNF in 1 week.     HTN - Continue PTA Atenolol    Atrial fibrillation, rate control - Continue PTA coumadin with pharmacy to dose.   Reason for Hospital Admission (Admitting Diagnosis):  Weakness
High fever of 104-105, sudden refusal to feeding, intervals of extreme lethargy and high pitched screaming while arching back (indication of severe pain), inability to make eye contact
An attorney reported that a female child received series of immunizations from birth to 18months of age that included 1 dose of Orimune, 2 doses of IPV, 3 doses of hepatitis B, 3 doses of Hib, 4 doses of DTP/DTaP, MMR, and varicella vaccines. It is alleged that, as a result of the cumulative toxicity from the mercury in the preservative found in the vaccines, that she now has been diagnosed with autism spectrum disorder: pervasive developmental disorder, not otherwise specified. The child was reportedly born a perfectly normal, healthy baby girl with APGAR scores within normal range. She reportedly reached every developmental milestone anticipated for all normally developing children. By 3 months of age, she was reportedly alert, cooing, responding to sounds, responding to others, and beginning to interact and recognize her parents. At 6 months of age, she reportedly regressed developmentally, losing milestones of neurological development previously achieved. She was reportedly withdrawn, unable to speak, unresponsive to her environment, lost language skills, motor skills, and affect, could no longer make eye contact, could not longer point her finger to recognize items, and could no longer interact with her mother and father. No further information was available as of the date of this report.
I tested positive for COVID-19 on 01/28/2022. My COVID-19 was mild, I had a cough, headache, fatigue and I had a fever for one night. My case was very mild. I missed 4 days of work.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -3.0 Celsius Degrees for 1172 hours, 15 Celsius Degrees for 56 hours, -1.11 Celsius Degrees for 80 hours and 8.33 Celsius Degrees for 392 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient received vaccine yesterday in left arm and complained of immediate "twitching/spasm" feeling in left bicep muscle. "Twitching/Spasm has lasted for 23 hours at time of reporting. Patient has attempted ice, heat, massage and ibuprofen to relieve spasm. Patient also reports continued tenderness at the injection site. There is no redness, swelling, or obvious deformity. There are no noted issues regarding strength or range of motion.
p/vax pt having nose bleed en route home;mom was advised to bring child back to clinic;upon arrival pt was found to be somnolent but arousable lt nostril had dried blood;
Right arm pain, redness, swelling, fever, abdomen pain. Treated with KEFLEX for right upper arm cellulitis.
severe bradycardia, arching, pallor & stiffness 8hr p/vax w/o colon change;
Strong fatigue that did not lift.  One week post injection, still very fatigued mentally and physically
Symptoms: Patient went to sleep in afternoon after vaccination w/FLUZONE QUAD. Awoke with itching on both sides of chin, which progressed to red blotches on face difficulty breathing, overall body rash, dizziness. Treatment: Patient waited 1 week to seek treatment < OTC BENADRYL ZYRTEC Cetaphil cleanser hydrocortisone valerate 0.24% ointment.
a sore right arm; nose running; eyes are burning; itchy; it almost feels like you have the flu; she  feels hot, then 30 minutes later will feels cold; overall tiredness; Chills; After the booster dose she was tired that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy) and INFLUENZA LIKE ILLNESS (it almost feels like you have the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 012M20A and 011L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received twenty-first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (After the booster dose she was tired that night). On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (overall tiredness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (After the booster dose she was tired that night), FATIGUE (overall tiredness) and CHILLS (Chills) outcome was unknown.            No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-403979 (Patient Link).
COVID-19 + on 10/24/2022, deceased 11/19/2022
I just noticed that my face was a little droopy on the left hand side. As the day progressed it seemed to get worse. I didn't have any other symptoms. Because of my age and medical history they checked if I had a stroke at the ER. I can tell now that the way I talk is a little different because I still have some of the asymmetry and numbness due on the left side of my tongue. The diagnosis they gave me was facial drooping.
Patient had a bright red rash 2 inches by 3 inches in diameter under the injection site.
numbness; This case was reported by a consumer via interactive digital media and described the occurrence of numbness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included oral herpes (Doctor confirmed the diagnosis as shinglesblisters.) and blister. Previously administered products included Shingles shot (received on an unknown date) and Mouthwash (need to do mouthwash sloushes in mouth 3 or 4 times a day).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingles vaccine.  Additional details provided as follow: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient never heard about shingles in mouth. The patient received original shingles shot which was came out a year or so before the shingles episode. The patient stated, one time occurrence of shingles was enough for him/her. The patient also received new shingles shot but still had numbness.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048290:same reporter US-GLAXOSMITHKLINE-US2021AMR048290:same reporter
Date of Vaccination.  Increased arm pain and fatigue and low grade fever  Day after vaccination,  Increasing fatigue and then chills and fever.  culminating in uncontrollable chills and a Tempt to 103.4 at around 38 hours post vaccination .  Fever departed around 42 hours post vaccination and fatigue and achiness resolved about 12 hours later.      Of note:  I had documented Covid 19 infection beginning 11/17/2021 .  No respiratory symptoms. just fatigue, lethargy and low grade fever with HA.
HEART PALPITATION; EXTREME WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heart palpitation. On 19-AUG-2021, the patient experienced extreme weakness. On 19-AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitation, extreme weakness, and fatigue. This report was non-serious.
second vaccine caused a bad flare up of my myasthenia gravis. We considered it a possible coincidence. Same thing happened after my booster. Not a coincidence. The vaccine triggered the myasthenia gravis both times.
The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.; The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) and PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) and PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient received vaccine from the vial that was punctured for more than 12 hours. Vial was first punctured on 23-May-2022 at 8:30 AM. Vial was initially stored in the refrigerator on 09-May-2022. Vial was stored at Room temperature post puncture. Vial did not undergo any temperature excursions.  No treatment information was provided.
Pfizer name] treatment under Emergency Use Authorization(EUA): Second dose receive 1/8/21 at 9 am - by 11 pm severe chills and am 1/9 substantial headache and body aches. Feel like I was hit by bus. Significant nasal congestion noted/
Bad rash all over body (forehead, scalp, elbow, shoulders, upper chest, lower back, hips, front thighs, front lower legs; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration administered in left arm on 11Feb2021 at 15:30 (at the age of 67-years-old) as single dose COVID-19 immunization. The patient's medical history includes year-round allergies (pollen, trees, bushes, grasses, dust). The patient's concomitant medications include lisinopril, lovastatin, fexofenadine hydrochloride (ALLERFEX) and cetirizine hydrochloride (ALLERTEC). It was reported that the patient experienced bad rash all over body (forehead, scalp, elbow, shoulders, upper chest, lower back, hips, front thighs, front lower legs) on 16Feb2021 at 20:45. It was reported that the AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event which included antihistamine and topical ointment. The outcome of the event was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included MS (had for 40 years but not ambulatory). On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband who was retired physician. The patient never had shingles before. The patient received a dose of SHINGRIX on the left arm. Within 2 days after vaccination, the patient's injection site had been moderately to severely painful at the injection site and it was radiating down perhaps 4 inches down the site of injection on her upper arm. The reporter did not want the company to contact the patient's physician. This case has been linked with the case US2019063878, reported by same reporter.
6/19/22: Noted tenderness behind R ear (thought it was glasses stem). Over a few hrs tenderness increased behind ear and progressed to below ear into neck and into scalp; eventually tender in front of ear;  next day, noted it had progressed to boney area at temple & around eye. No shooting pains, only very tender to touch. Thought maybe dental?  6/23/22: Saw dentist. Most tenderness faded by this time  No dental findings, but she noted slight R facial swelling.   A few days later same symptoms started on left side, same progression of tenderness  (around ear, temple, eye, but not into neck or scalp), again, slowly fading over several days. No shooting pains, only tender to touch. Some swelling, especially in L temple/eyelid area. 6/30/22: L side facial tenderness completely resolved, slight swelling persists. R side symptoms completely resolved. Currently symptoms completely resolved.
Rash around eyes, spreading to rest of face. Hands and arm purple/red. Muscle twitches in arm and chest, rapid heart rate, chills and sweating.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Ep7534), in right arm, on 16Apr2021 as dose 2, single (Lot number: Er8731), in right arm, on 22Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 02Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 02Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient is a 5 year old female brought by mother with 1 day history of fever and swelling, redness and blotches to left thigh. Temperature elevated to 100 degrees at home. The patient was given immunizations on 7/23/07. The mother has been giving Motrin prn. Parents observations of the patient at home are reduced activity, normal appetite and normal fluid intake.
While administering vaccine in left deltoid hub of needle disconnected from syringe therefore full dose not administered. Pt received additional injection in right arm. We used medical hypodermic needle 23 G that was provided w/ vaccine supply.  Vaccine supply unaffected as there was an 11th dose in the vial
Has not received the 2nd dose yet passed 40 day period; Positive for covid after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-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 PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, SARS-CoV-2 test: (Positive) Positive for covid after the 1st dose.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: TCR attached- outcome and Second dose information added.
Information has been received from a Registered Nurse (RN) concerning an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. Since 22-SEP-2016, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX for prophylaxis (lot number M025867 with an expiration date of 24-MAY-2018, lot number M024683 with an expiration date of 18-MAY-2018, lot number reported as M024675 with an expiration date of 18-MAY-2018 and lot number L050956 with an expiration date of 17-DEC-2017) (strength, dosage, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. Lot number M024675 has been verified to be a valid lot number for VARIVAX. Follow up information was received on 21-NOV-2016 from the registered nurse via a telephone call. The nurse stated that she would research and fax the patient identifiers and any dates of vaccinations. Additional information has been requested. Sender's Comments: MERCK 1610USA001176:Mfr number.
This spontaneous report as received from a nurse refers to a unspecified 17 year old patient. On 13-APR-2018 the patient was vaccinated with first dose of GARDASIL 9 from lot N014464 expiry date 19-DEC-2017 for prophylaxis.  On 09-FEB-2018, the patient received the second dose of GARDASIL 9 from lot N019104 expiry date 3-FEB-2020 and on 13-APR-2018, the patient received third dose of GARDASIL 9 from lot reported as "N02969"  expiry date 17-MAY-2020 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA007716.
Lightheadedness , dizziness  pt stated he had not eaten since early morning declined going to ER
This case was reported by a nurse and described a 23 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Medication error.  Moderna Bivalent was given as the 1st dose in the series.  Nurse administering the injection thought the patient was requesting a booster.  She did not verify previous doses.  Patient is not exhibiting any signs or symptoms at this time.
Today (10/26/2018) child had 7 minute seizure. Mother states worse she has ever had. Vaccine she had was riv4?
Fever-like symptoms for 24 hours - beginning 24 hours after vaccination. Temperature 99.3 24 hours after vaccination, body aches, fatigue. Soreness at vaccination route for 72 hours.
Pain at injection site, then the next day, a 6? long rash developed that was very sensitive to the touch. It lasted 7 days, and then settled into a bruise at the lower part of the rash.
Client was in car in observation area post vaccination. Per clients wife client stated that he was dizzy then fell unconscious for about 10 seconds. med activated. Client stated that he felt lightheaded. Client evaluation by  med.  All vitals normal Alert and Oriented x4.
12AUG94 t101, watery eyes, runny nose, cheeks, swollen down to jawline; 13AUG94 t 102-103 throughtout day; swelling progressed to neck; PMD prescribed Amoxicillin over phone;
Pt recv vax on 2/1/99; on 2/2/99 pt exp red, blotchy rash w/ itching on left thigh vax site; tx=Benadryl;Annual follow-up dated 08/29/00 provided no addtional data.
Underage before the 5/12 approval for Pfizer vaccine Suspected falsification of DOB ? unable to contact guardian