chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red eruption on chest/back; papular eruption on chest/back; itchy eruption on chest/back; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red eruption on chest/back), RASH PAPULAR (papular eruption on chest/back) and PRURITUS (itchy eruption on chest/back) outcome was unknown.        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.   Concomitant product information was not provided by the reporter.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 17-MAR-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given dose 1 of GARDASIL 9 in exam room. 1 minute after administration, was brought into another room to perform lipid panel ( which consists of finger stick and small blood sample.) After obtaining sample, patient had syncopal episode. Syncopal episode was about 4 minutes after vaccine was given. Patient regained consciousness within 1 minute. Had slight nausea without episode of emesis. Patient laid on the floor for about 5 minutes. Patient was then examined by Dr. and given clearance. He then went to sitting position and was given juice. After another 5 minutes, patient was able to stand and was escorted out by mother.
Per patient's phone call 5/9/19 she felt depressed after the shot and the depressed mood lasted 5 weeks.
Patient found having a syncopal episode then later vomited; regained consciousness after 5 seconds Patient felt fatigued and lightheaded Patient agreed to stay longer  in monitoring Stated he has history when getting vaccinated of feeling dizzy or nauseated  Patient refused medical transport and signed AMA form Patient advised to be picked up , but decided to go home by self Stated feeling better
It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 4/20/00. Reportedly, on 4/24/00, the pt experienced a seizure. The pt is a known epileptic on Lamictal. Further information requested.
No treatment/no reaction. Varicella given too soon after MMR. Time occurred 3/22/11 1344.
Some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours; This is a spontaneous report from a contactable other health care professional. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Dec2020 11:30 at single dose, at left arm for COVID-19 immunization.  Medical history included arthritis. On 31Dec2020 21:30, it was reported that the patient experienced some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours. The patient did not receive treatment for the event. The outcome of the event was recovered.   Information about lot/batch number has been requested.
Moderna covid-19 vaccine eua. About 15 min after injection I felt hot (very unusual for me), then dizzy,  racing heart, weak then very nauseous.  I told the nurse.  He asked me to lay down.  I did not get worse.  After 20 min or so I sat up and did not feel worse.  Just stable nausea and dizzy.  I asked if I could leave.  After verifying I had people at home I was allowed to go.  I felt exhausted and nauseous for the rest of the day.  I was confused the next morning about what day it was and had some hives at injection site.  I felt normal after figuring out what day it was.  I walked 8 miles and aside from the hives at the injection site was normal.  One week later I had headache, exhaustion and had an uncomfortable rash at the site.  The rash is still on my arm.    Should I get the second dose?
Patient was waiting his 15 minutes in Observation. He passed out and the nurse noticed and walked over to help hold him up. When paramedics walked over he was awake and talking. Patient stated he felt fine and walked out to private area with the paramedics. Upon sitting in the chair he was unconscious again and paramedics transferred him onto stretcher and transported him to nearby hospital. He states this happens when he gets injections.
Heart was beating fast; Felt dizzy in the morning and at night before bed; This is a spontaneous report received from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: el9266) via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and asthmatic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included metformin (MANUFACTURER UNKNOWN) and FARXIGA from unknown dates and for unknown indications, unknown if it is ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Feb2021 at 12:30, the patient reported that her heart was beating fast and she felt dizzy for 7 days in the morning and at night before bed. The patient did not receive any treatment for the events. At the time of this report in 2021 the event heart rate increased was recovered and in Mar2021 the event felt dizzy was recovered.   No follow-up attempts are needed. No further information is expected.
I experienced jaw pain separate from a headache in mid-afternoon following my first injection of the vaccine.
A 39 year old male pt experienced fever, fatigue, malaise and body aches after receiving post exposure treatment with RabAvert. The pt's past medical history included hypertension and back pain. Concomitant medication included tramadol, Hytrin, clonidine, Klonopin, Trazodone, and Protonix. The pt received RabAvert 1ml IM on 25Jun04 and the last dose of the series on 09Jul04 (day 14). Body ache, fever, fatigue, and malaise began after his first dose and have continued through the course of treatment on day 14. Follow up received 20Jul04: Tylenol was used for treatment of symptoms. The reporter stated it was unk if the events had resolved.
Within 2 hours of dose he experienced severe leg pain and by evening had a severe case of what he thought was laryngitis. Leg pain continued to get worse until Friday and he couldn't get out of bed.  Patient went to ER on Sunday morning because the pain was so severe he couldn't walk. The pain was in his knees, lower legs, ankles, and feet.  The ER doctor sent him to hospital to be admitted.  The patient was in hospital for 6 days.  The patient was given pain meds and a rheumatologist was called in and she diagnosed him with gout.  they treated him with 4 doses of Anakinra.  That medication helped.  The patient currently is in pain if he is walking around pain level between a 5-8.  The pain is less if he remains seated.  He experiences the most discomfort when standing from a seated position mostly in his knees.
chills, red swollen eyes, h/a, weak knees, fatigue; took Tavist D & Advil;
Severe muscle soreness.  Dizziness feeling faint   Lasted approximately 12 hours.   Slight to moderate headache everyday since vaccine
Raised, hardened, itchy lump at injection site. In the shape of a circle about 1-1.5" in diameter
Admitted for breakthrough COVID infection. Treating with Dexamethsone and Redemsivir
This non-serious spontaneous case, initially received on 09-Feb-2018, was reported by a pharmacist and concerns a 47-year-old female adult patient. The patient had no diabetes, heart disease or asthma before getting the injection. Concomitant medications were not reported. On 21-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195241, expiry date: 30-Jun-2018). On the same day, after vaccination, the patient developed tingling in feet and tremors (patient stated that event started at the night, hence unsure of the onset date). Subsequently, the patient was diagnosed with neuropathy and was under prescriber's care, but she has no idea of what treatment she was given. At the time of this report, the patient had not recovered from the events. Follow-up received from the pharmacist on 09-Mar-2018: It was reported that, the patient had no diabetes, heart disease or asthma before getting the injection. The patient was under a provider's care, but she has no idea of what treatment she was given. Upon internal review, it was realized that the onset date of the event neuropathy was not captured. Hence, onset date of the event was added in the event tab. The narrative was amended accordingly. Follow-up received from the pharmacist on 02-Apr-2018: The reporter confirmed that, the start date of diagnosis (neuropathy) was 21-Jan-2018. The narrative was amended accordingly.
Patient developed BLE edema and pain approimately 15 days after her 4th COVID vaccine.  She was diagnosed with an Occlusive DVT of the RLE.
Baby not sleeping well, fussy, not drinking enough fluids, not making enough urine. Baby went to hospital for intussusception.
He developed papular urticaria diffusely of extremities, trunk, back and palms.
I started to experience swelling in my left calf about a month after the vaccination. It still happens.
The symptoms started with head congestion. My wife was positive for COVID-19. I tested myself for COVID-19 daily. That morning, I tested positive for COVID-19 as well. I went to a walk-in clinic. They verified the diagnosis of COVID-19. They gave me medication to take twice a day for five days. I don't remember the name of it. It was not Paxlovid, because the doctor said it would have reacted with my current medication. I didn't have the same symptoms as my wife. I just felt like I had a head cold. It took about a week and a half to for my symptoms to clear.
several unidentified pt recv vax & devel fever & an inj site rxn characterized by warmth, bruising, & swelling;No further details were known as of the date of this report;
became pale limp, cyanotic; 4 hrs p/immun lasting 30 mins;
ACHE/ACHY CHILLS; CHILLS/ACHY CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number.   No concomitant medications were reported. On an unspecified date, the subject experienced ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210420375.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
A report has been received from a health professional concerning a 1 year od, female subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the administration to 20 month old which started on 21 OCT 2013. The outcome of the event of administration to 20 month old is unknown. The report was considered to be non-serious.
Fever greater that 102 for the first two days. Elevated temp greater than 99 five days. Nausea, vomiting, diarrhea 5 days after injection. Daily headaches 12 days post injection.
Patient complained of itching of arm starting 2 weeks after receiving vaccination, continues until today's date (11/12/18).
On 1/2/2020 client received first dose of Varicella vaccine. Client states that 4 days later, area where vaccine was given became redden and progressed to swelling and ecchymosis. Site, left arm assessed today and there is still some swelling and ecchymosis. Client instructed, if needed to place ice for no longer than 10 minutes to area on and off. Client educated about vaccines. Client provided with this writer phone # to call agency if area worsens. Client verbalized understanding.
Noticed tinnitus in 2 hrs. and has progressively gotten worse. It is moderate boardering extreme
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm soreness"; CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "body aches". Therapeutic measures were taken as a result of pain in extremity, chills, pain. Additional Information: Events were resolved with paracetamol (TYLENOL) as treatment within 24hrs. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/29/04 TC from mother-area on right leg with erythema approx. 5-7cm in diameter with hard central area, no fever, area not warm to touch- call if persists recommended wm compress; Benadryl for itching
Not adverse event but reportable event.  Patient has received both COVID-19 vaccinations due in series and is more than 2 weeks out from vaccination and developed COVID-19, patient tested positive for COVID-19  3/10/2021 form for breakthrough case sent to Epidemiology   Dose 1: 12/19/2020 Pfizer EK5730 in left deltoid Dose 2: 1/8/2021 Pfizer EL3246 in left deltoid Tested positive for COVID-19 3/10/2021
Fatigued during workout the day after the vaccine (this was the booster - 3rd dose of the Moderna  COVID vaccine).    4 days after vaccine came down with terrible cold.  Symptoms were sufficiently severe I received  cold meds from a tele-health doctor, and I took a PCR COVID test on day 3 of the symptoms.  The  COVID test was negative, and the cold has subsided (symptoms have been treated successfully by the meds prescribed by the tele-health visit).
Fever, headache, sinus congestion, throat soreness, body aches, chills, sweating and fatigue.
No additional AE reported; A pharmacist reported an expired GARDASIL 9 was administered to a patient. The caller declined to provide patient demographics at this time. The vaccine had no prior temperature excursions. No additional AE reported. No PQC.; Point in the process the medication error ocurred? Dispensing/The pharmacist was interrupted while checking the product/The doctor's office missed checking the expiration date before administration; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 01-APR-2022, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S023476, expiration date 26-MAR-2022, for prophylaxis (strength, route and frequency were not reported). The vaccine had no prior temperature excursions. No additional adverse events reported  This report is non-valid due to lack of identifiable patient.  Follow-up information was received from the pharmacist on 12-MAY-2022. This case was referring to a 31-year-old female patient.  On 01-APR-2022, the patient was vaccinated with an expired first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly (anatomical site of administration was not provided).  It was stated that the medication error occurred during the dispensing process as the pharmacist was interrupted while checking the product and the doctor's office missed checking the expiration date before administration (product dispensing error).   The reporter considered expired product administered to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient medical history was not reported. There were no concomitant medications. On 25Apr2021 the patient experienced swelling in left lymph node on same side as shot, exacerbating small varicose vein pain, swelling extended through bicep to elbow. Prior to vaccination, the patient not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is the third year I have had the influenza vaccine. Every year I go to a walk in clinic locally to obtain the injection.  Today is day 8 or 9 after my vaccine and I am having the exact symptoms as I had two years prior.  I am a Registered Nurse (retired) so I know now that this thrd time is not by coincidence.  I feel like I am dying.  I have a low grade fever everyday that starts at about 11 a.m., my entire body aches and I am fatigued...I literally feel like I am dying.  Last night my airway became obstructed minimally and I could not catch my breath.  I feel nauseated and I can barely eat.  Every doctor and nurse I speak with essentilly thinks I am wrong and that I have the flu...I know this is not true.  I am a healthy lady and I ride a horse and work in the community daily.  I am really sick from the vaccine and I will never take it again if I survive this round of symptomology
Adverse effect of other vaccines and biological substances, initial encounter on 2022-06-30, Cellulitis of left upper limb on 2022-07-01.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. Patient's medical history was reported as red rash on face and hand after receiving unspecified cortisone injection on unspecified date. On 17-APR-2014, the patient was vaccinated with ZOSTAVAX vial 19400, plaque-forming units (PFU) (lot number J011335, expiry date 20-DEC-2014), 0.65 ml /once, subcutaneous. Concomitant therapy was unspecified. Approximately on an unknown date in April 2014, the patient experienced allergic reaction at injection site of ZOSTAVAX. Pharmacist further clarified that patient described reaction as raised area involving left deltoid area and about the size of her hand, with no pain or no itching. No medical intervention was given and patient continues to monitor site of reaction. No lab diagnostics studies were performed. No product quality complaint was involved. The outcome of allergic reaction at injection site was unknown. The reporters causality assessment for the event allergic reaction at injection site with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
Fever, decreased activity, rash, hives, purpura (diagnosed as HSP). Given Tylenol, Motrin and Benadryl.
Red raised bumps at site of MMRV vaccine. Developed approx. 16  days post vaccine. No other problems. Referred to Dr.'s for evaluation.
"I could feel the stuff (vaccine) go up my arm as far as my neck then it went away". No visible bump at site at this time. On 12/7/00, I noticed a rash on my back near shoulder blade. Developed abdomen rash on 12/10/00 was  on chest previously. Denies pain at this time but had major itching. "She had hives on her abdomen on 12/10/00 but was not visible 12/11/00. Also a fine rash on abdomen.
Red ear inflamed and swollen, red blotchy patches on neck and anterior chest.  50 mg Benadryl PO.
Patient inadvertently got a 12+ covid vaccine as the rest of the family received them, yet the patient was ineligible. Parents did not report any adverse effects