chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter a 21 year old female with penicillin allergy and sulfonamide allergy and no other medical history who in May 2008, was vaccinated with a first dose of GARDASIL. Concomitant therapy included a birth control medicine (name not provided). One week after receiving GARDASIL, the patient developed a bad eye infection in her left eye. The patient's vision with this eye had become worse and had a scar on this eye. Unspecified medical attention was sought. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received form a physician which reorted the patient with amoxicillin allergy developed herpes simplex virus keratitis on 20-MAY-2008. At last on 11-JUL-2008, there was no known of aquried infection. Decreased vision was surveyed. Tapering medications was given. There was no known illness at the time of vaccination. The outcome of herpes simplex virus keratitis was not reported. Follow-up information was received from a primary physician reported that on 13-MAY-2008, the patient was vaccinated intramusculary with a first dose of GARDASIL into left arm (lot# 660387/1967U). On 20-MAY-2008, the patient developed keratitis and uveitis. Vision 20/100; herpes was not definitely diagnosed, but patient placed on one and a half weeks treatment of VALTREX. Conditions were not disabling or life threatening. On 11-JUL-2008 (after VALTREX was complete), the patient was seen by ophthalmologist (corneal specialist), whose consult note stated "compromised secondary to scarring", but reported vision as 20/20. The patient was seen again by physician on 22-JUL-2008, the patient doing fine (recovered). At next visit, the patient would have blood work done to check for herpes. The physician said there was absolutely no connected between the patient's eye disorder and GARDASIL use. This report no longer meets the criteria for expedited submission to the FDA. The AE term was changed from herpetic keratitis to keratitis and uveitis and was considered non serious. Additional information is not expected.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female of unknown race and ethnic origin. 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: 1805025 and expiry date: 09-Jul-2021) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUL-2021, the patient started getting slight coughs, chills, slight fever, runny nose and extremely tired. On 14-JUL-2021 the patient tested for PCR COVID test which resulted positive on 15-JUL-2021 with confirmed covid-19 test and confirmed clinical vaccination failure. The patient is worried about how she got COVID as she was using a mask everywhere she went, didn't go out much, and social distanced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection as of 16-JUL-2021, she still had all the same symptoms but was feeing less tired and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738448-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Inappropriate sinus tachycardia.  Heart rate increased withstanding or any activity.  Extremely elevated after few minutes of exercise.  Shortness of breath with any activity due to elevated heart rate
Febrile seizure happened on 1/12, 2 days after 6 month vaccines per mom, was very hot and fussy, had seizure at hom at LR temp was 103. no records available Since then pt has been well, eating well, breast and table foods, happy
Became dizzy and lightheaded while at check out bumping his chin on the counter, placed in chair, put on exam table vital signs taken, ice applied no apparent injury, denies complaints. Left in ten minutes after same.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On 23-JUN-2014 the patient was vaccinated with GARDASIL (Dose, frequent and route were unknown) which was improperly stored. Concomitant medications were not reported. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. No adverse effects were reported. No product quality complaint (PQC) was reported. This case is linked to case # 1407USA000289 (same reporter link). Additional information has been requested.
Uncontrollably shaking, fever, heart racing, chest hurting, stomach aching, about passed out, clammy, pale.
Patient received the powder portion of Menveo mixed with Pfizer COVID diluent.  Both the Menveo and Pfizer pediatric COVID vials have same colored top. Pt. observed for 15mins with no adverse event and/or outcome.  Pt will be advised to return to repeat COVID vaccine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 03-Sep-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-344282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow-up received on 12-oct-2021 contain significant information about Patient demographic details added, medical history was added
This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009161, orally. It was reported. that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
When patient did not show up for his 2nd dose appointment (Moderna Covid vaccine) I tried to call him and checked his profile where I discovered he had received his first dose on 3/19/21 and then his second dose  on 3/28/21; 9 days after rather than 28 days after. I have not been able to contact the patient as the phone is not set up for voicemail and there has been no answer when I've tried to call. I do not know why he was given the second dose so close to the first dose.
not feeling well at all; body is killing me, like i got hit by a truck; bones are hurting; unable to work; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued) outcome was unknown.        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.
I have developed moderately severe kidney disease.  My tubules show extensive damage.  I have received annual physicals for years and my kidneys have been healthy until last years labs, after getting the vaccine.  I have no risk factors- no hypertension, no diabetes, no heart or lung disease.   I do have PAC's, hence the bystolic.  And, I have hyperlipidemia, regulated with diet and crestor.   I eat well, am of ideal weight.  I work out throughout the week and and am a very active 60 year old.
R09.02 HYPOXEMIA 3/14/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA R09.02 HYPOXEMIA 3/14/2023 CHF EXACERBATION, UNSPECIFIED
Pain in left arm. Knot on left arm in place shot was given. No taste or smell.
My left arm was super sore and then I noticed a lump in my left clavicle area that moved from either side of my clavicle and super uncomfortable. I also had a lump in my left arm pit that didn't move but was super tender.
my tongue & the roof of my mouth started burning; my tongue & the roof of my mouth started burning; My tong also swelled enough that I bite the side of my tongue at night; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581) second dose via an unspecified route of administration, administered in left arm on 19Feb2021 13:45 as SINGLE DOSE for covid-19 immunisation. Medical history included burning tongue reaction when prescribed Zoloft, Buspiron, Effexor, so immediately stopped and burning subsided within 24 hours and also get a burning tongue reaction to walnuts and fresh pineapple, all from an unknown date and unknown if ongoing. Patient did not test positive for Covid prior to or post vaccination. Concomitant medications included ATORVASTIN, GABAPENTIN and METHENAMINE. On 27Jan2021 at 11:30 AM patient received first dose of Bnt162b2 (lot number=EL9265 in left arm). On 19Feb2021 after receiving 2nd vaccine shot patient stated that my tongue and the roof of my mouth started burning. My tongue also swelled enough that I bite the side of my tongue at night, enough to break the skin of my tongue. It has been 6 days since the 2nd shot and the burning has not diminished. Almost impossible to sleep at night. Doctor gave some prednisone yesterday to see if the auto immune reaction would diminish. The burning did not diminish. The patient was very fearful to take a booster shot in 6 months and no one was able to assure her. Patient was given Prednisone and lidocaine rinse as therapeutic measure for the events. Outcome of the events was not recovered.
Information has been received from a physician concerning a 6 month old male with no pertinent medical history or drug allergies who on 30-OCT-2007 was vaccinated PO with his third 2.0 ml dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of PedvaxHib (manufacturer unknown), a dose of (PREVNAR), a dose of (PEDIARIX) and a dose of influenza virus vaccine (unspecified). On 01-NOV-2007 the patient experienced blood in the stool which was still occurring at the time of the report. The patient was seen by the physician and the following labs and diagnostic studies were performed: Clostridium difficile, rotavirus, salmonella, and shigella and allergy testing for egg, soy and milk. The patient was not recovered. There was no product quality complaint. Upon internal review, blood in the stool was determined to be an other important medical event. Follow-up information has been received from a physician indicating that the patient's lab diagnostic studies performed: Clostridium difficile, salmonella, shigella, rotavirus, egg, soy and milk allergy testing were all negative. The patient was not diagnosed with intussusception. The physician also noted the patient recovered. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe
Patient vaccinated with VZV on 8/14/97. Pt presented with shingles on right palm to ulnar area at elbow. Diagnosis was confirmed visually by a pediatric dermatologist on 3/12/01.
Headacke, vomits, nauseas, chest pain, tremors, noise in my ears, anxiety, sorethroat , muscle pain. Change in period cicle, tireness.
Vertigo, dizziness, nausea, vomiting, sudden hearing loss, asymmetrical right sensorineural hearing loss, tinnitus, peripheral vertigo, benign paroxysmal positional vertigo.
Patient experienced chills headache and shoulder pain starting the evening of the day he received his flu shot. Patient will be starting physical therapy shortly due to his shoulder pain.
Nose started bleeding spontaneously approximately 4 hours after getting the vaccine.  Fast running and gushing. Treated by pinching nose and inserting tissue into right nostril. Lasted about 1/2 hour. Started again at approximately 4 pm - not as fast running as before - same treatment. Started bleeding today (3/14) at around 3 pm. Still bleeding but slower.
Fever and chills began the night of my vaccine and lasted through the next day. Fever peaked at 101 and lasted a whole day. Accompanied by body aches, arm soreness, fatigue. Took ibuprofen to help fever. Ultimately the effects were resolved by the morning of 4/30/2021 or roughly 48 hours.
Aches; chills; facial redness; tired; This is a spontaneous report from a contactable consumer or other non-health care professional. A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN 6206, Expiry date not reported) dose 1 via an unspecified route of administration, administered in Left arm on 05Mar2021 11:30 (age at vaccination 35 years old) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL EXTRA STRENGTH), ibuprofen both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 at 17:00 the patient experienced aches, chills, facial redness and tired. Patient did not receive treatment for adverse events. Outcome of events was recovered on unspecified date in Mar2021.     Follow-up attempts completed. No further information expected.
feel like I got hit by a bus/Still feeling awful, it feels like my skin; woke up at 5 this morning with all over muscle and joint aches and chills; woke up at 5 this morning with all over muscle and joint aches and chills; woke up at 5 this morning with all over muscle and joint aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills) 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) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills). At the time of the report, FEELING ABNORMAL (feel like I got hit by a bus/Still feeling awful, it feels like my skin), MYALGIA (woke up at 5 this morning with all over muscle and joint aches and chills), ARTHRALGIA (woke up at 5 this morning with all over muscle and joint aches and chills) and CHILLS (woke up at 5 this morning with all over muscle and joint aches and chills) outcome was unknown.            No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-220983 (Patient Link).
her injection arm was sore; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 031L20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired). At the time of the report, VACCINATION SITE PAIN (her injection arm was sore), NAUSEA (Nausea) and FATIGUE (Tired) outcome was unknown.            No Concomitant product use was reported.  The patient reported their experiences after receiving the 2nd dose of the Moderna Covid-19 Vaccine. After the 2nd dose, the patient had nausea, was tired, and their injection arm was sore. The patent was concerned that they had no reaction after the booster and wondered if the vaccine decreased in effectiveness as it was getting closer to the expiration date.  No treatment information was provided.
This is a 41 y/o man who received his routine annual antrax booster immunization on 5/03/08. He is a member of the Air National Guard.  Once he got home, he developed abdominal cramping and around 6 pm, diarrhea started having several episodes in a 2-3 hours period.  It was clear diarrhea without blood.  No more diarrhea since his last episode the same day.  After the diarrhea he developed malaise and weakness, which is not severe, but still present.  Also has mild generalized body icthing but without rash.  He recalls that the last time he had the antrax booster, he developed tingling sensations in the arm associated with itching- he never reported it.  He denies ear pain, nasal congestion, sore throat, difficulty swallowing or breathing, chest pain, palpitations, DOE, nausea, vomiting , skin rash except for redness where the immunization was placed, focal sensory or motor loss or LEE.  He refers mild headache since last night.
This spontaneous report as received from an healthcare worker (also reported as medical assistant) refers to 15 unspecified patients of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # M004116 expiry date 12-OCT-2017) which was stored at temperature 31.4 F for a total time of 1000 minutes. There was no previous temperature excursion reported. The call was because of data logger (therapy type: digital data logger). No adverse symptoms reported. There was no product quality complaint. Additional information has been requested.
pain in the arm; injection site itchy; injection site swollen; feels warm in the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feels warm in the injection site), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (injection site swollen) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced VACCINATION SITE WARMTH (feels warm in the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, VACCINATION SITE WARMTH (feels warm in the injection site), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sore injection site; Burning in throat; Severe headache; Nausea; Insomnia; Indigestion; Stomach pain; Heart palpitations; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Aug2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's, asthma and known allergies to gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Aug2021 at 16:15, the patient experienced sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore injection site, burning in throat, severe headache with nausea, insomnia, indigestion, stomach pain and heart palpitations was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received second dose COVID-19 vaccine (Moderna) on 4/23/21 - injection site was on left arm. On day 2 after the injection, +fatigue, body aches, rash showed up on face (bilateral cheeks), front of neck, chest. The rash was red and flat (not itchy), injection site pain and redness. On day 3, rash worsened - rash spread on face and became a little darker red. Took benadryl x2 (with no improvement in the rash). Today, body aches are improved, arm does not hurt as bad, there is still some redness and warmth at the injection site. Rash is worse in terms of redness and itching. The rash is more spread across the front of neck (there is some rash behind both ears). There are some raised bumps on the bilateral cheeks and chest. Fatigue has improved as well.