chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elbows burning red biopsy done, knees broken out with open sores, Bruising below the knee on both legs, Left knee 6 inch red warm circle over knee cap, fingers broke out with puncture marks, Scalp swollen right side and base of neck, Lymphatic system backed up,  Red V shape marks on legs and shoulder, Lesions on legs, purple round spots on legs, Tips of fingers burning and extremely painful, open wounds on elbow and knees,  - 5 rounds of different antibiotics, steroid creams 4 types, biopsies, finally prednisone, helped on my 2nd round now. The antibiotics and steroid creams did nothing. when prednisone wears off I start to break out on the elbows and knees again. Tbis has been 3 plus months May 2nd through todays date 07/28/2021.
Systemic: see comments-Medium, Additional Details: pt was given expired vial of moderna vaccine; the vial was punctured at 11 am on May 30 2021 and shot was given June 1.
Psoriatic arthritis flare in hand and wrist; sores on fingers; Psoriasis in hair and ears; This is a solicited report from a Non-Interventional Study based on information received by Pfizer from AbbVie, MFR Control No: 21K-163-4140736-00. A non-contactable 53-year-old female consumer (patient) reported for herself that:  Solicited report from a consumer of an adult female with events of non-serious sores on fingers, psoriatic arthritis flare in hand and wrist and psoriasis in hair and ears with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced sores on fingers, psoriatic arthritis flare in hand and wrist and psoriasis in hair and ears. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 25Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 16Apr2021 patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  The reporter's causality for the event(s) of SORES ON FINGERS and PSORIATIC ARTHRITIS FLARE IN HAND AND WRIST with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of PSORIASIS IN HAIR AND EARS was not provided. The reporter's causality for all the events with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. Patient's relevant medical history, diagnostic tests, treatment, event onset dates etc would have allowed better to assess the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Psoriatic arthritis aggravated, Skin lesion and Psoriasis cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
motion sickness; Pain in injection spot; dizziness; headache; nausea; fatigue; weakness; This is a spontaneous report from a contactable consumer, the patient. A 21-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 22Feb2021 at 08:30 (at the age of 21-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and COVID-19 (prior to vaccination), both as of unspecified dates. Concomitant medications included sertraline hydrochloride (ZOLOFT) and bupropion. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Feb2021 at 15:45, the patient experienced pain in the injection spot, dizziness, motion sickness, headache, nausea, fatigue and weakness. The patient was not treated for the events. Since the vaccination, the patient had no been tested for COVID-19. The clinical outcome of pain in the injection spot, dizziness, motion sickness, headache, nausea, fatigue and weakness was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
MMR was administered, few minutes later PPD skin test recvd; few minutes later blood was being drawn fr finger prick for lead/hct/hgb pt started vomiting, got pale & started perspiring, felt faint; condition lasted approx 15 mins; BP70/50;
No to little reaction to first shot.  Developed severe case of SHINGLES  within days after second shot on 202/25/21.     Shingles developed despite patient having received the Shingles 2-shot vaccine in 2018.
pt recvd vax 2APR93 & did well until 10APR93 when spiked temp of 104 ax; also had red macpapular rash;
My shoulder started hurting immediately & it persisted and it still hurts now. I went to clinic to get my shoulder looked at & I was sweating so the Dr ordered me to go to ER & it was discovered I had anemia.
Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination.
rib cage is sore; fever of 104 Degrees Farenheight; joints all felt like they were on fire; I could not walk; Joints felt inflamed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I could not walk), ARTHRITIS (Joints felt inflamed), MUSCULOSKELETAL CHEST PAIN (rib cage is sore), PYREXIA (fever of 104 Degrees Farenheight) and ARTHRALGIA (joints all felt like they were on fire) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), SALBUTAMOL (ALBUTEROL HFA), EPINEPHRINE (EPIPEN), POTASSIUM CHLORIDE, HYDROCHLOROTHIAZIDE, AMLODIPINE, LOSARTAN, ISOSORBIDE MONONITRATE, ACETYLSALICYLIC ACID (ASPIRIN 81), METOPROLOL SUCCINATE, GABAPENTIN and GABAPENTIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced GAIT DISTURBANCE (I could not walk), ARTHRITIS (Joints felt inflamed), PYREXIA (fever of 104 Degrees Farenheight) and ARTHRALGIA (joints all felt like they were on fire). On 31-Mar-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (rib cage is sore). On 31-Mar-2021, GAIT DISTURBANCE (I could not walk), ARTHRITIS (Joints felt inflamed), PYREXIA (fever of 104 Degrees Farenheight) and ARTHRALGIA (joints all felt like they were on fire) had resolved. At the time of the report, MUSCULOSKELETAL CHEST PAIN (rib cage is sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Pyrexia: 104 (High) 104 Degrees.         Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-063833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063833:First dose vaccination
Fever  (over 100 .2)  and chills;  lasted several hours.  Symptoms resolved completely  within 24 hours of vaccination.
REDNESS, SWELLING, TENDERNESS, PAIN 7X7 INCHES IN DIA TO LEFT ARM. WAS GIVEN IBUPROFEN DAILY
Information has been received from a registered nurse concerning a 12 month old female with diabetes who in approximately 1999 was vaccinated with a dose of varicella virus vaccine live. Shortly thereafter the child was insulin dependent. Prescription drug treatment was required. Unspecified medical attention was sought. There was no product quality complaint involved. The nurse said that she did not have a release from the parents and refused any additional information . At the time of this report, the child was 4 years old. The insulin dependent diabetes was considered to be immediately life-threatening and disabling. Additional information has been requested.
Cellulitis on 10/17 Extreme Redness 3?x5? gradually decreasing over 5 days  Some  intermittent red streaks within red area  Extreme pain Fever  Nausea  Swelling and hardness  Diarrhea on 10/22/2019
Lymphadenopathy in the L arm.  Large node in the axilla measuring about 2 cm with several small pea to peanut sized nodes throughout the forearm and upper arm.  Tender, lasted greater than one months duration so far. Some generalized swelling to the L arm.
BODY ACHES; FEEL HOT; FEEL OVERLY TIRED; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced feel hot. On 09-APR-2021, the subject experienced feel overly tired. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, chills, feel hot, and feel overly tired. This report was non-serious.
The following morning when she woke up had chills, temperature, very bad headache, and a head cold.  Went to HD, they sent her home and to report to us and monitor it.  If she didn't get better to go to ER or Dr.  1/20/21, felt chills, woke up in pool of sweat, bad headache, and mucousy with runny  nose and still having that symptom.   1/21/21 feeling like she may be getting a little better, but FU with her PCP tomorrow.  No difficulty breathing, cold like symptoms.  Feels like she doesn't have a temperature.  Finally does not have a headache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Lot number: Ew0167), in left arm, on 26May2021 as dose 2, single (Lot number: Ew0191), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: Ff8841), in right arm and on 23Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos" (unspecified if ongoing); "Tarlov cyst disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 01Dec2021; NUVIGIL, start date: 01Dec2021; MYRBETRIQ, start date: 01Feb2022, stop date: 05Jan2023; CLARITIN [LORATADINE], start date: 01Dec2021; LYRICA, start date: 01Dec2021. Past drug history included: Tramadol, reaction(s): "Allergy"; Tricyclics, reaction(s): "drug allergy". 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 with Paxlovid from 05Jan2023 to 05Jan2023.
tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Meningitis ACWY (received Meningitis ACWY on an unknown date in 2014), HPV vaccine (received HPV on an unknown date) and Hepatitis B vaccine (received Hepatitis B vaccine on an unknown date).   On 23rd August 2021, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient's mother. The patient received 1st dose of Bexsero intramuscularly in left deltoid and felt extremely tired for 2 days. The patient's mother wanted to know if this was common. The patient did not had dose second of Bexsero yet. The reporter did not wanted to share patient's doctor's contact information. The reporter did not consent to follow up.
The evening of FluMist booster patient had an episode of vomiting with following unresponsiveness and possible right sided twitching.  Was afebrile during this episode. 1 month following was diagnosed with partial seizure disorder with similar symptoms- vomiting with following unresponsiveness and right sided twitching.  Was afebrile during this episode and had negative MRI, electrolytes, and no history of trauma or ingestion.
Diarrhea; He was sick; Vomiting; This is a spontaneous report from a contactable consumer.   A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 25Jan2021 (age at vaccination: 79 years) as DOSE 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 06Jan2021 as dose 1, single for covid-19 immunization. On 07Feb2021 02:30, the patient experienced diarrhea, vomiting and was sick. The reporter stated that on Sunday morning at about 00:30, he woke up and he started having diarrhea and about 2:30 am, he started vomiting, he was sick all day long yesterday and he is still sick this morning. The reporter got to go through all his paperwork and all and it said was that this could be some symptoms of the COVID Vaccine. The outcome of the event illness was not recovered, and all the other events was unknown.  Follow-up attempts completed. No further information expected.
p/vax pt in office w/1 day hx of lt face weakness on 6/3/99;dx Bell's Palsy;
A report has been received from a health professional via medical representative concerning a patient of unknown age and gender. The patient's medical history, concomitant diseases and medications were not reported. On 02-OCT-2015, the patient was given dose of FLUMIST quadrivalent, (intranasal), 0.2 millilitres in once/single administration and developed allergic reaction. At the time of reporting, the outcome of the event of had an allergic reaction was unknown. The report was considered to be non-serious by the company physician.
Hives and itching developed within 10 minutes following  injection on hands and neck, improving within 35 minutes.
Dizziness, Headache, Myalgia, NauseaVomiting, Chills/Shakes Narrative:
31MAY93 5 days p/vax pt rt eye continuously drawning towards nose; rt eye remained straight; p/observing this new condition sought rx; accommodative esotropia;
first dose/04-Jan-2019/not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021168350, US2020079556, US2019096333, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168350:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter
Fever, chills, diarrhea for over 24 hours, weakness, lightheaded. Took Advil, Immodium, ginger ale, sports drink, broth. Felt like the flu without nasal congestion. Everything I drank, came out the other end. However, there wasn't any vomiting. After about 48 hours, diarrhea stopped and I was able to eat some chicken soup. My first 3 vaccines were Pfizer and I didn't experience these symptoms. Unfortunately, the day of my appointment, the pharmacy had an issue with their Pfizer vaccine not being at the correct temperature during delivery to their pharmacy.
Sharp pain in upper L chest beginning within 15 min of immunization.  Over next hour and a half, pain became milder and intermittent. Was no rash or skin discoloration. No SOB or sweating or fever or radiation of pain to L arm or jaw.
The evening after receiving the Fluzone HD and Prenvar 13, pt developed a tingling in her tongue that progressed to a 9 out of 10 pain in her throat, difficulty swallowing and eyelid swelling. She did not have shortness of breath or rash. She took two 25mg doses of diphenhydramine and called EMS. She was evaluated at hospital and was given 60mg prednisone and 20mg famotidine. She was discharged with prescriptions for 20mg famotidine bid and a prednisone dose pack. She did not fill these prescriptions because her symptoms had largely resolved by the end of the day on 9/22. She was re-evaluated in clinic on 9/24 and no long-term symptoms or harm were noted.
Physician Discharge Summary   Patient ID:   56 y.o.    Admit Date:  7/31/2022   Discharge Date: 8/1/22   Principal Dx/ Final Dx: Angina at rest   Relevant Inpt Dx: Principal Problem:   Angina at rest Active Problems:   Stage 1 mild COPD by GOLD classification   Chronic pulmonary embolism   CAD (coronary artery disease)   Type 2 diabetes mellitus without complication, without long-term current use of insulin   Essential hypertension       HPI:   Hospital Course:   This 56 year old man was admitted with chest pain.  He did not have MI.  He did test positive for covid.  He was seen by cardiology.  Decision made for medical treatment with further evaluation planned when seen in office in 2 weeks
I woke up with a mildly nauseous stomach. I thought I would feel better after taking a shower. When I got out of the shower at about 8:15 am, I couldn't stand up. I thought I was going to faint. I was nauseous, dry heaving, my heart racing and sweating profusely. I was able to put my pajamas back on at one point. This lasted 45-60 minutes. At the end, my pajamas were completely soaked through. Once I was able to stand and leave the bathroom, I was weak and mildly nauseous the remainder of the day.
expired vaccine kept in refrigerator; No adverse event; Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022) and PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator).    No concomitant medications were reported.  Number of doses/vials were 7 doses/1 vial.  The Healthcare Professional (HCP) did not know the date the vial was initially stored in the refrigerator but stated that vaccines were usually put in refrigerator a week before administration.  The reporter wanted to know about the stability of this lot number and recommendation for next steps for the patients impacted due to this.  The patients had not reported any adverse reactions.  No treatment medications were reported.
Red bullseye around vaccination site 1.5-2 hours after, swollen and red next morning
This case was reported by a nurse and described the occurrence of lesion on forehead in a unk patient who received FLUARIX QUADRIVALENT. On 30th September 2014, the patient received FLUARIX QUADRIVALENT (unknown). On 1st October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced lesion on forehead. On an unknown date, the outcome of the lesion on forehead was unknown. It was unknown if the reporter considered the lesion on forehead to be related to FLUARIX QUADRIVALENT. Additional information received: Nurse called to inquiry about a potential adverse event. She wanted to know if a forehead lesion has been reported after the use of FLUARIX QIV. She did not have the patient's name or any other information. The adverse event was left on her phone. She did not want to give her address, but she said she would call back after speaking to the patient. The vaccine was administered at a flu clinic the prior day.
This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. The patients' relevant medical and past drug histories, concomitant medications, and relevant laboratory data are unknown. On 17-OCT-2016, the patients were vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date: 30-MAY-2018, 0.5 ml, intramuscularly. The patients possibly received a dose that had undergone a temperature excursion. The patients had not experienced any adverse reactions and had not been provided any treatments. It was unknown if the patients continue to received GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
12/17/11 - very stiff arm & tricep, decreased movement, dizziness during AM hours. Dizziness ended Monday afternoon (12/19/11). 12/19/11 - redness, warmth, decreased movement. 12/22/11 - no redness, no stiffness, sx's subsided.